View source for Table of Content

== Table of Content ==

=== Module 1: Ethics, methodology and regulations ===

==== Fundamentals of ethics ====

===== 1.1.1 — Clinical research - objectives =====
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| [[Reference:ICH ICH E6 Guideline R3 (2025) Appendix B. B4]] || G || EN || B.4 Trial Design The scientific integrity of the trial and the reliability of the results from the trial substantially depend on the trial design. A description of the trial design should include: ...
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| [[Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - Clinical Research]] || G || EN || […] Clinical research is indispensable for resolving public health challenges. Clinical research studies can be thought of as spanning five generic areas of activity: • measuring the magnitude and ...
|-
| [[Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.4]] || G || EN || 1.4 Persistent challenges to clinical trial enablement There is an urgent need to avoid wasteful procedures and make clinical trials more efficient so that they can be done on an adequate scale to ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.3]] || MD || EN || 6.3 Justification for the design of the clinical investigation [...] The clinical investigation shall be designed to evaluate […]
|}

===== 1.1.2 — Historical development of the Clinical Research =====

===== 1.1.3 — Fundamentals of ethics =====
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| [[Reference:INT Nuremberg Code 1947 Code]] || G || EN || 1. The voluntary consent of the human subject is absolutely essential.[…] 2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means ...
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| [[Reference:WMA Declaration of Helsinki 2024 -]] || G || EN || GENERAL PRINCIPLES [...] 7. The primary purpose of medical research involving human participants is to generate knowledge to understand the causes, development and effects of diseases; improve ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - Good Clinical Practice (GCP)]] || HM || EN || Good Clinical Practice (GCP) A standard for clinical studies which encompasses the design, conduct, monitoring, termination, audit, analyses, reporting and documentation of the studies and which ...
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| [[Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 WHO Principles of GCP]] || G || EN || WHO Principles of GCP Principle 1: Research involving humans should be scientifi cally sound and conducted in accordance with basic ethical principles, which have their origin in the Declaration of ...
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| [[Reference:EUR European Bioethics Convention 1997 -]] || G || EN || The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, otherwise known as the European Convention on Bioethics or the ...
|}

===== 1.1.4 — The 11 principles of GCP =====
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| [[Reference:ICH ICH E6 Guideline R3 (2025) I]] || G || EN || Good Clinical Practice (GCP) is an international, ethical, scientific and quality standard for the conduct of trials that involve human participants. Clinical trials conducted in accordance with this ...
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| [[Reference:ICH ICH E6 Guideline R3 (2025) II]] || G || EN || II. PRINCIPLES OF ICH GCP [...] 1. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with GCP ...
|}

==== Methodological basics ====

===== 1.2.1 — Definition =====
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| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Clinical Trial]] || G || EN || Clinical Trial Any interventional investigation in human participants intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational ...
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| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial]] || HM || EN || clinical trial A systematic study on pharmaceutical products in human subjects (including patients and other volunteers) in order to discover or verify the effects of and/or identify any adverse ...
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| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.8]] || MD || EN || clinical investigation […]
|}

===== 1.2.2 — Delimitations of Clinical Trials/Studies =====
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| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - pharmaceutical product]] || HM || EN || pharmaceutical product Any substance or combination of substances which has a therapeutic, prophylactic or diagnostic use, or is intended to modify physiological functions, and is presented in a ...
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| [[Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - NIS]] || G || EN || [...] Non-interventional studies are observational in nature (hence sometimes known as observational studies), in which health outcomes are typically compared between individuals who received or were ...
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| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I 6.3]] || MD || EN || I.6.3 Non-interventional clinical investigation […]
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| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 1]] || HM || EN || Definitions For the purposes of this Regulation, the following definitions also apply: (1) ‘Clinical study’ means any investigation in relation to humans intended: (a) to discover or verify the ...
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| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 2]] || HM || EN || (2) ‘Clinical trial’ means a clinical study which fulfils any of the following conditions: (a) the assignment of the subject to a particular therapeutic strategy is decided in advance and does not ...
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| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 3]] || HM || EN || (3) ‘Low-intervention clinical trial’ means a clinical trial which fulfils all of the following conditions: (a) the investigational medicinal products, excluding placebos, are authorised; (b) ...
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| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 4]] || HM || EN || (4) ‘Non-interventional study’ means a clinical study other than a clinical trial;
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| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 4 – 8]] || MD || EN || (4) ‘active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the ...
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| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 10 – 12]] || MD || EN || Definitions (10) ‘procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose; (11) ‘system’ means a ...
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| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 14]] || MD || EN || (14) ‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken;
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| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 46]] || MD || EN || (46) ‘investigational device’ means a device that is assessed in a clinical investigation;
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| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 52]] || MD || EN || Conformity assessment procedures 1. Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity ...
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| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 45]] || MD || EN || Definitions (45) ‘clinical investigation’ means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device;
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| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 62]] || MD || EN || Definitions (62) ‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user;
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 4 – 6]] || IVD || EN || Definitions (4) ‘accessory for an in vitro diagnostic medical device’ means an article which, whilst not being itself an in vitro diagnostic medical device, is intended by its manufacturer to be used ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 7 – 9]] || IVD || EN || Definitions (7) ‘companion diagnostic’ means a device which is essential for the safe and effective use of a corresponding medicinal product to: (a) identify, before and/or during treatment, patients ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 11]] || IVD || EN || Definitions (11) ‘kit’ means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof;
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 14]] || IVD || EN || Definitions (14) ‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken;
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 45]] || IVD || EN || Definitions (45) ‘device for performance study’ means a device intended by the manufacturer to be used in a performance study.
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 48]] || IVD || EN || Conformity assessment procedures 1. Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 42]] || IVD || EN || Definitions (42) ‘performance study’ means a study undertaken to establish or confirm the analytical or clinical performance of a device;
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 58]] || IVD || EN || Definitions (58) ‘informed consent’ means a subject's free and voluntary expression of his or her willingness to participate in a particular performance study, after having been informed of all ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 23]] || HM || DE || § 4 Sonstige Begriffsbestimmungen (23) Klinische Prüfung ist eine solche im Sinne des Artikels 2 Absatz 2 Nummer 2 der Verordnung (EU) Nr. 536/2014 des Europäischen Parlaments und des Rates vom 16. ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 34]] || HM || DE || (34) Eine Unbedenklichkeitsstudie ist jede Studie zu einem zugelassenen Arzneimittel, die durchgeführt wird, um ein Sicherheitsrisiko zu ermitteln, zu beschreiben oder zu quantifizieren, das ...
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| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 f Absatz 1 – 3]] || HM || DE || § 63f Allgemeine Voraussetzungen für nichtinterventionelle Unbedenklichkeitsstudien (1) Nichtinterventionelle Unbedenklichkeitsstudien, die vom Inhaber der Zulassung auf eigene Veranlassung ...
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| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 g Absatz 1 – 2]] || HM || DE || § 63g Besondere Voraussetzungen für angeordnete nichtinterventionelle Unbedenklichkeitsstudien (1) Der Inhaber der Zulassung hat bei nichtinterventionellen Unbedenklichkeitsstudien, die nach § 28 ...
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| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 47-001]] || MD || DE || § 47 Anforderungen an sonstige klinische Prüfungen (1) Eine sonstige klinische Prüfung eines Produktes darf auch bei Vorliegen der Voraussetzungen des Artikels 82 Absatz 1 der Verordnung (EU) ...
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| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3]] || MD || DE || § 3 Ergänzende Begriffsbestimmungen Ergänzend zu den Begriffsbestimmungen des Artikels 2 der Verordnung (EU) 2017/745 und des Artikels 2 der Verordnung (EU) 2017/746 bezeichnet im Sinne dieses ...
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| [[Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-001]] || NIS || DE || 1. Nichtinterventionelle Studien (NIS) 1.1. Definition einer nichtinterventionellen Studie [...] Dokumentationssystematisierende und den Arzt-Patienten-Dialog strukturierende Fragebögen können als ...
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| [[Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.2]] || NIS || DE || 1.2. Anzeigepflichtige nichtinterventionelle Studien Bei Durchführung von nichtinterventionellen Studien gelten gegenüber den zuständigen Bundesoberbehörden Anzeigepflichten für: - ...
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| [[Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.1]] || NIS || DE || 2.1. Definition einer Anwendungsbeobachtung [...] Bei Anwendungsbeobachtungen handelt es sich um Untersuchungen, die dazu bestimmt sind, Erkenntnisse bei der Anwendung zugelassener oder registrierter ...
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| [[Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.1]] || NIS || DE || 3. Nichtinterventionelle Unbedenklichkeitsstudien nach der Zulassung (Postauthorisation safety studies: PASS) 3.1. Definition einer Unbedenklichkeitsstudie Eine Unbedenklichkeitsstudie ist gemäß § 4 ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 clinical trial]] || HM || EN || [...] “clinical trial” means any investigation in human subjects, other than a non-interventional trial, intended— (a)to discover or verify the clinical, pharmacological or other pharmacodynamic ...
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| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 non-interventional trial]] || HM || EN || [...] “non-interventional trial” means a study of one or more medicinal products which have a marketing authorization, where the following conditions are met— (a)the products are prescribed in the ...
|-
| [[Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (a)]] || HM || EN || Definitions For the purposes of this Directive the following definitions shall apply: (a)‘clinical trial’: any investigation in human subjects intended to discover or verify the clinical, ...
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| [[Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (c)]] || HM || EN || (c)‘non-interventional trial’: a study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the ...
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| [[Reference:GBR The Human Medicines Regulations 2012 01-Jan-2025 Article 51B]] || HM || EN || Application for UKMA(UK) relating to generic medicinal products 51B.—(1) An applicant for a UKMA(UK) for a generic medicinal product may, by way of derogation from paragraph 10 of Schedule 8, omit ...
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| [[Reference:GBR Directive 93/42/EEC 11-Oct-2007 ANNEX X 2.1]] || MD || EN || 2. Clinical investigations 2.1. Objectives The objectives of clinical investigation are: — to verify that, under normal conditions of use, the performance of the devices conform to those referred to ...
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| [[Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 18]] || MD || EN || Approved bodies and the conformity assessment procedures for general medical devices 18.—(1) An approved body which is responsible for carrying out a conformity assessmentprocedure in relation to a ...
|-
| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (c)]] || G || EN || (c) Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug ...
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| [[Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.110 (a) - (b) (1)]] || G || EN || § 56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. (a) The Food and Drug Administration has ...
|-
| [[Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (b)]] || G || EN || (b) Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the ...
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| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - Clinical investigation]] || HM || EN || Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is any use of ...
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| [[Reference:USA 21 CFR Part 320 09-Apr-2025 § 320.22]] || HM || EN || § 320.22 Criteria for waiver of evidence of in vivo bioavailability or bioequivalence. […]
|-
| [[Reference:USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 -]] || G || EN || https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html Research Categories Research Categories 1. Clinical studies of drugs and ...
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| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.1]] || MD || EN || § 812.1 Scope. (a) […] This part provides procedures for the conduct of clinical investigations of devices. An approved investigational device exemption (IDE) permits a device that otherwise would be ...
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| [[Reference:USA NIH - Glossary 27-May-2025 Observational study]] || G || EN || Observational study A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, ...
|}

===== 1.2.3 — Differentiation: Medical Devices/In Vitro Diagnostic/Food/Cosmetic Product =====
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| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-001]] || MD || EN || medical device […]
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| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 1 - 3]] || MD || EN || Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other ...
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| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 2 – 3]] || IVD || EN || Definitions (2) ‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, ...
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| [[Reference:EU ; GBR Regulation (EC) No 178/2002 - Food Safety 01-Jul-2022 Article 2]] || G || EN || Definition of ‘food’ For the purposes of this Regulation, ‘food’ (or ‘foodstuff’) means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably ...
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| [[Reference:EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023 Article 2]] || G || EN || 1. For the purposes of this Regulation, the following definitions shall apply: (a) ‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the ...
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| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 1 – 2]] || HM || DE || § 2 Arzneimittelbegriff (1) Arzneimittel im Sinne dieses Gesetzes sind Arzneimittel, die zur Anwendung bei Menschen bestimmt sind. Dies sind Stoffe oder Zubereitungen aus Stoffen, 1. die zur ...
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| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 3]] || HM || DE || (3) Arzneimittel im Sinne dieses Gesetzes sind nicht 1. Tierarzneimittel im Sinne des Artikels 4 Nummer 1 der Verordnung (EU) 2019/6 des Europäischen Parlaments und des Rates vom 11. Dezember 2018 ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 3a–4]] || HM || DE || (3a) Arzneimittel sind auch Erzeugnisse, die Stoffe oder Zubereitungen aus Stoffen sind oder enthalten, die unter Berücksichtigung aller Eigenschaften des Erzeugnisses unter eine Begriffsbestimmung ...
|-
| [[Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 2 in vitro diagnostic medical device]] || MD || EN || “in vitro diagnostic medical device” means a medical device which— (a) is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus,equipment or system, whether used alone ...
|-
| [[Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 2 medical device]] || MD || EN || “medical device” means any instrument, apparatus, appliance, software, material or otherarticle, whether used alone or in combination, together with any accessories, including thesoftware intended by ...
|-
| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3]] || G || EN || § 50.3 Definitions. As used in this part: (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040 et seq. as amended (21 U.S.C. 321-392)). (b) Application for ...
|-
| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (k)-001]] || G || EN || (k) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or ...
|-
| [[Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.104 (d)]] || G || EN || § 56.104 Exemptions from IRB requirement. The following categories of clinical investigations are exempt from the requirements of this part for IRB review: [...] (d) Taste and food quality ...
|-
| [[Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.104]] || G || EN || § 46.104 Exempt research. […]
|-
| [[Reference:USA U.S. Code Title 21 30-Sep-2023 § 321 (f)]] || G || EN || (f)The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
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| [[Reference:USA U.S. Code Title 21 30-Sep-2023 § 321 (i)]] || G || EN || (i)The term “cosmetic” means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, ...
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| [[Reference:USA U.S. Code Title 21 30-Sep-2023 § 321 (h)]] || G || EN || (h)(1) The term ‘‘device’’ (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement, machine, ...
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| [[Reference:USA 21 CFR Part 809 06-May-2024 § 809.3 (a)]] || G || EN || § 809.3 Definitions. (a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the ...
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| [[Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 510 (k)]] || G || EN || (k) Each person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device ...
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| [[Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 512 (f)]] || G || EN || (f)(1) Any device intended for human use which was not introduced or delivered for introduction into interstate commerce for commercial distribution before the date of the enactment of this section ...
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| [[Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 737 (8)]] || G || EN || (8) The term ‘‘de novo classification request’’ means a request made under section 513(f)(2)(A) with respect to the classification of a device.
|}

===== 1.2.4 — Risk class of medical devices =====
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| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 51]] || MD || EN || Classification of devices 1. Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification shall be ...
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| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex VIII]] || MD || EN || CLASSIFICATION RULES
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| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 47]] || IVD || EN || Classification of devices 1. Devices shall be divided into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out ...
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| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex VIII]] || IVD || EN || CLASSIFICATION RULES
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| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 6]] || MD || DE || § 6 Klassifizierung von Produkten, Feststellung des rechtlichen Status, Einstufung von Produkten der Klasse I, Genehmigungspflicht einer klinischen Prüfung oder einer Leistungsstudie (1) ...
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| [[Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 9]] || MD || EN || Classification 1. Devices shall be divided into Classes I, IIa, IIb and III. Classification shall be carried out in accordance with Annex IX. 2. In the event of a dispute between the manufacturer and ...
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| [[Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Section 513]] || MD || EN || CLASSIFICATION OF DEVICES INTENDED FOR HUMAN USE Device Classes SEC. 513. [21 U.S.C. 360c] (a)(1) There are established the following classes of devices intended for human use: (A) CLASS I, GENERAL ...
|}

===== 1.2.5 — Study Types - Human medicines =====
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| [[Reference:ICH ICH E8 Guideline R1 (2021) ANNEX: TYPES OF CLINICAL STUDIES]] || HM || EN || „Human Pharmacology“ „Exploratory“ „Confirmatory“ „Post-Approval“ https://www.ich.org/page/efficacy-guidelines
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| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial Phases]] || HM || EN || clinical trial [...] Clinical trials are generally classified into Phases I to IV. It is not possible to draw distinct lines between the phases, and diverging opinions about details and methodology ...
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| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.21]] || HM || EN || § 312.21 Phases of an investigation. An IND may be submitted for one or more phases of an investigation. The clinical investigation of a previously untested drug is generally divided into three ...
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| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.85]] || HM || EN || § 312.85 Phase 4 studies. Concurrent with marketing approval, FDA may seek agreement from the sponsor to conduct certain postmarketing (phase 4) studies to delineate additional information about the ...
|}

===== 1.2.6 — Study Types - Medical Devices =====
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| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I]] || MD || EN || Clinical development stages [...] 1.4 Type of clinical investigation design [...] 1.4.2 Exploratory clinical investigation [...] 1.4.3 Confirmatory clinical investigation [...] 1.4.4 Observational ...
|}

===== 1.2.7 — Study Designs =====
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| [[Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 3]] || HM || EN || 3. Sponsor 3.1 Engagement and Communication […] 3.1.1 Engaging patients, patient advocacy groups and their communities, as appropriate, can help ensure the successful integration and implementation ...
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| [[Reference:ICH ICH E8 Guideline R1 (2021) -]] || HM || EN || ICH guideline E8 (R1) on general considerations for clinical studies
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| [[Reference:ICH ICH E8 Guideline R1 (2021) 3.3.5]] || HM || EN || 3.3.5 Critical to Quality Factors in Operational Practice The foundation of a successful study is a protocol that is both scientifically sound and operationally feasible. A feasibility assessment ...
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| [[Reference:ICH ICH E9 Guideline 1998 III]] || HM || EN || III. TRIAL DESIGN CONSIDERATIONS 3.1 Design Configuration 3.1.1 Parallel Group Design […] 3.1.2 Crossover Design […] 3.1.3 Factorial Designs […] 3.2 Multicentre Trials […] 3.3 Type of Comparison ...
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| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.1]] || HM || EN || 9.1 Experimental design The scientific integrity of a clinical trial and the credibility of the data produced depend primarily on the design of the trial. In the case of comparative trials, the ...
|-
| [[Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Overview of the Clinical Research Process]] || HM || EN || Key trial activities include: 1. Development of the trial protocol […] 2. Development of standard operating procedures (SOPs) […] 3. Development of support systems and tools […] 4. Generation and ...
|-
| [[Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 2.]] || HM || EN || [...] The risk to subject safety in a clinical trial mainly stems from two sources: the IMP and the trial procedures. For example, if a clinical trial is considered low intervention from an IMP ...
|-
| [[Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.1]] || HM || EN || A risk based quality management system for clinical trials should include the following steps: - critical process and data identification - risk identification - risk evaluation - risk control - risk ...
|-
| [[Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 -]] || HM || EN || [...] Question 1: Important considerations for the planning and conduct of complex clinical trials [...] Question 2: Which additional considerations are needed for the design and conduct of master ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 1]] || MD || EN || General requirements regarding clinical investigations conducted to demonstrate conformity of devices 1. Clinical investigations shall be designed, authorised, conducted, recorded and reported in ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 3]] || MD || EN || 3. Clinical investigations shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participating in a clinical investigation are protected and ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 74]] || MD || EN || Clinical investigations regarding devices bearing the CE marking 1. Where a clinical investigation is to be conducted to further assess, within the scope of its intended purpose, a device which ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 82]] || MD || EN || Requirements regarding other clinical investigations 1. Clinical investigations, not performed pursuant to any of the purposes listed in Article 62(1), shall comply with the provisions of Article 62 ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 1 – 3]] || IVD || EN || Additional requirements for certain performance studies 1. Any performance study: (a) in which surgically invasive sample-taking is done only for the purpose of the performance study; (b) that is an ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5-001]] || IVD || EN || 5. A performance study as referred to in paragraph 1 may be conducted only where all of the following conditions are met: (a) the performance study is the subject of an authorisation by the Member ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 70]] || IVD || EN || Performance studies regarding devices bearing the CE marking 1. Where a performance study is to be conducted to further assess, within the scope of its intended purpose, a device which already bears ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 Absatz 4]] || MD || DE || 4. „sonstige klinische Prüfung“ eines Produktes eine klinische Prüfung, die a) nicht Teil eines systematischen und geplanten Prozesses zur Produktentwicklung oder der Produktbeobachtung eines ...
|-
| [[Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 2]] || NIS || DE || Leitlinie 2 (Forschungsfrage) Die Planung jeder epidemiologischen Studie erfordert explizite und operationalisierbare Fragestellungen, die spezifisch und präzise formuliert sein müssen. Die Auswahl ...
|-
| [[Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.3 - 3.6]] || NIS || DE || Leitlinie 3 (Studienplan und Operationshandbuch) [...] Epidemiologische Studientypen umfassen alle zur Beantwortung epidemiologischer Forschungsfragen geeigneten Studiendesigns. Die Terminologie ist ...
|-
| [[Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.1]] || NIS || DE || Leitlinie 6 (Qualitätssicherung) [...] Empfehlung 6.1 In jeder epidemiologischen Untersuchung, bei der Primärdaten erhoben werden, ist zu prüfen, ob vor Beginn der Hauptstudie eine separate ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (d)]] || HM || EN || § 312.23 IND content and format. […] (6) Protocols. [...] (d) A description of the design of the study, including the kind of control group to be used, if any, and a description of methods to be used ...
|-
| [[Reference:USA 21 CFR Part 314 09-Apr-2025 § 314.126]] || HM || EN || § 314.126 Adequate and well-controlled studies. (a) The purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences, such as spontaneous ...
|}

===== 1.2.8 — Foundation of biometrics =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E9 Guideline - Addendum R1 20-Nov-2019 -]] || HM || EN || STATISTICAL PRINCIPLES FOR CLINICAL TRIALS E9 ADDENDUM ON ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS TO THE GUIDELINE ON STATISTICAL PRINCIPLES FOR CLINICAL TRIALS E9 (R1)
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.3]] || HM || EN || 9.3 Statistical analysis The type(s) of statistical analyses to be used must be specified in the protocol, and any other subsequent deviations from this plan should be justified and described in the ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.7]] || MD || EN || A.7 Statistical design and analysis
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter I Section 2]] || MD || EN || 2. Methods 2.1. Clinical investigations shall be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge and defined in such a way as ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIII Part A Section 2.3]] || IVD || EN || 2.3. Methods for clinical performance studies 2.3.1. Clinical performance study design type Clinical performance studies shall be designed in such a way as to maximize the relevance of the data while ...
|}

==== Legal basis of requirements ====

==== Regulatory Overview ====

==== Competent Authority, Ethics committee and submissions ====

===== 1.5.1 — European Medicine Agency =====

===== 1.5.2 — National Competent Authorities =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Regulatory Authorities]] || G || EN || Regulatory Authorities Bodies having the power to regulate, including those that review submitted protocols and clinical data and those that conduct inspections. These bodies are sometimes referred ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11]] || HM || EN || 11. ROLE OF THE DRUG REGULATORY AUTHORITY The role of governments is to provide the legal framework for clinical trials. The aim should be twofold: (i) to protect the safety and rights of the ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 77]] || HM || DE || Bestimmung der zuständigen Bundesoberbehörden und sonstige Bestimmungen § 77 Zuständige Bundesoberbehörde,Verordnungsermächtigung (1) Zuständige Bundesoberbehörde ist das Bundesinstitut für ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 85]] || MD || DE || § 85 Zuständigkeiten und Aufgaben der Behörden (1) Zuständige Behörden im Sinne der Verordnung (EU) 2017/745, der Verordnung (EU) 2017/746 und dieses Gesetzes sind, soweit in den Absätzen 2 bis 6 ...
|-
| [[Reference:DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024 § 65]] || MD || DE || § 65 Zuständige Bundesoberbehörde, Verordnungsermächtigung (1) Zuständige Bundesoberbehörde im Sinne dieses Gesetzes ist 1. das Paul-Ehrlich-Institut a) für immunologische Tierarzneimittel im ...
|-
| [[Reference:FRA Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II 16-May-2025 L5311-1]] || G || FR || Article L5311 I.-L'Agence nationale de sécurité du médicament et des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé. II.-L'agence ...
|-
| [[Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.1-001]] || G || EN || § 54.1 Purpose. (a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in marketing applications, required by law, for new human drugs and biological products and marketing ...
|}

===== 1.5.3 — Ethics Committees =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Institutional Review Board (IRB)/Independent Ethics Committee (IEC)]] || G || EN || Institutional Review Board (IRB)/Independent Ethics Committee (IEC) An independent body (a review board or a committee, institutional, regional, national or supranational) constituted of medical ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 1]] || G || EN || 1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) […] 1.1 Submission and Communication [...] 1.2 Responsibilities [...] 1.3 Composition, Functions and Operations [...] 1.4 ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - ethics committee]] || HM || EN || ethics committee An independent body (a review board or a committee, institutional, regional or national), constituted of medical professionals and non-medical members, whose responsibility it is to ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Introduction]] || HM || EN || 3.2 Ethics committee The role of the ethics committee (or other board responsible for reviewing the trial) is to ensure the protection of the rights and welfare of human subjects participating in ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.24]] || MD || EN || ethics committee EC […]
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.26]] || MD || EN || independent not involved in the development of the investigational device or the conduct of a clinical investigation (3.8), except for their specifically assigned responsibilities, in order to avoid ...
|-
| [[Reference:WMA Declaration of Helsinki 2024 Paragraph 23]] || G || EN || Research Ethics Committees 23. The protocol must be submitted for consideration, comment, guidance, and approval to the concerned research ethics committee before the research begins. This committee ...
|-
| [[Reference:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 20]] || G || EN || Guideline 2: Ethical review committees [...] Commentary on Guideline 2 [...] Failure to submit a protocol to the committee should be considered a clear and serious violation of ethical standards. ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41a]] || G || DE || § 41a Registrierungsverfahren für Ethik-Kommissionen (1) An dem Verfahren zur Bewertung eines Antrags auf Genehmigung einer klinischen Prüfung nach der Verordnung (EU) Nr. 536/2014 dürfen nur ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41b]] || G || DE || § 41b Verfahrensordnung und Geschäftsverteilungsplan (1) Das Bundesministerium erstellt durch Rechtsverordnung mit Zustimmung des Bundesrates eine Verfahrensordnung über die Zusammenarbeit der ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41c]] || G || DE || § 41c Verordnungsermächtigung Das Bundesministerium wird ermächtigt, durch Rechtsverordnung, die nicht der Zustimmung des Bundesrates bedarf, eine Bundes-Ethik-Kommission bei dem Bundesinstitut für ...
|-
| [[Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 4]] || G || DE || § 4 Geschäftsverteilungsplan (1) Der Geschäftsverteilungsplan legt die Reihenfolge fest, in der die registrierten Ethik-Kommissionen für die Bearbeitung eines Antrags auf Genehmigung einer klinischen ...
|-
| [[Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 5]] || G || DE || § 5 Validierung (1) Die zuständige Ethik-Kommission gibt ihre Stellungnahme nach § 40 Absatz 3 Satz 2 des Arzneimittelgesetzes oder ihre Bewertung nach § 40 Absatz 3 Satz 5 des Arzneimittelgesetzes ...
|-
| [[Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 1 1.1 ; 1.3]] || NIS || DE || Leitlinie 1 (Ethik) [...] Empfehlung 1.1 Vor der Durchführung einer epidemiologischen Studie soll die Stellungnahme einer Ethikkommission eingeholt werden. [...] Empfehlung 1.3 Bei der Festlegung der ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 relevant ethics committee]] || HM || EN || […] “relevant ethics committee”, in relation to a clinical trial, means— (a)in a case where an ethics committee has given a favourable opinion in relation to that trial and paragraph 13 of Schedule 2 ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 5-6]] || HM || EN || ETHICS COMMITTEES United Kingdom Ethics Committees Authority 5.—(1) The body responsible for establishing, recognising and monitoring ethics committees in the United Kingdom in accordance with these ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 7-10]] || HM || EN || 7.—(1) Subject to paragraph (3), the Authority may, by a notice in writing, recognise a committee as an ethics committee for the purposes of these Regulations if— (a)an application in relation to ...
|-
| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (i)]] || G || EN || (i) Institutional review board (IRB) means any board, committee, or other group formally designated by an institution to review biomedical research involving humans as subjects, to approve the ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - IEC]] || HM || EN || Independent ethics committee (IEC) means a review panel that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (f)]] || MD || EN || (f) Institutional review board (IRB) means any board, committee, or other group formally designated by an institution to review biomedical research involving subjects and established, operated, and ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (t)]] || MD || EN || (t) Independent ethics committee (IEC) means an independent review panel that is responsible for ensuring the protection of the rights, safety, and well-being of subjects involved in a clinical ...
|-
| [[Reference:USA 21 CFR Part 56 09-Apr-2025 -]] || G || EN || Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A—General Part 56 Institutional Review Boards https://www.ecfr.gov/current/title-21
|-
| [[Reference:USA 21 CFR Part 56 09-Apr-2025 Subpart B]] || G || EN || Subpart B—Organization and Personnel § 56.106 Registration […] § 56.107 IRB membership. […]
|-
| [[Reference:USA 21 CFR Part 56 09-Apr-2025 Subpart C]] || G || EN || Subpart C—IRB Functions and Operations § 56.108 IRB functions and operations. […] § 56.109 IRB review of research. […] (f) An IRB shall conduct continuing review of research covered by these ...
|-
| [[Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.107 - § 46.112]] || G || EN || § 46.107 IRB membership. […] § 46.108 IRB functions and operations. […] § 46.109 IRB review of research. […] § 46.110 Expedited review procedures for certain kinds of research involving no more than ...
|-
| [[Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.115]] || G || EN || § 46.115 IRB records. […]
|-
| [[Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart E]] || G || EN || Subpart E—Registration of Institutional Review Boards […] § 46.501 What IRBs must be registered? Each IRB that is designated by an institution under an assurance of compliance approved for ...
|}

===== 1.5.4 — Submission of a Clinical Study =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.8]] || G || EN || 3. SPONSOR [...] 3.8 Communication with IRB/IEC and Regulatory Authority(ies) 3.8.1 Notification/Submission to Regulatory Authority(ies) In accordance with applicable regulatory requirement(s), ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Consultation]] || HM || EN || 3.2 Ethics committee [...] The investigator, or the investigator and the sponsor, must consult the relevant ethics committee(s) regarding the suitability of a proposed clinical trial protocol ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.8 - 4.9]] || HM || EN || 4.8 Notification of the trial or submission to the drug regulatory authority As governed by national regulations, the investigator, sponsor, or investigator jointly with the sponsor, should give ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 4]] || G || EN || Prior authorisation A clinical trial shall be subject to scientific and ethical review and shall be authorised in accordance with this Regulation. The ethical review shall be performed by an ethics ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 5]] || G || EN || Submission of an application 1. In order to obtain an authorisation, the sponsor shall submit an application dossier to the intended Member States concerned through the portal referred to in Article ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 6]] || G || EN || Assessment report — Aspects covered by Part I 1. The reporting Member State shall assess the application […] (a) Whether the clinical trial is a low-intervention clinical trial, where claimed by the ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 7]] || G || EN || Assessment report — Aspects covered by Part II 1. Each Member State concerned shall assess, for its own territory, the application with respect to the following aspects: (a) compliance with the ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 8]] || G || EN || Decision on the clinical trial 1. Each Member State concerned shall notify the sponsor through the EU portal as to whether the clinical trial is authorised, whether it is authorised subject to ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 9]] || G || EN || Persons assessing the application 1. Member States shall ensure that the persons validating and assessing the application do not have conflicts of interest, are independent of the sponsor, of the ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 10]] || G || EN || Specific considerations for vulnerable populations 1. Where the subjects are minors, specific consideration shall be given to the assessment of the application for authorisation of a clinical trial ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 11]] || G || EN || Submission and assessment of applications limited to aspects covered by Part I or Part II of the assessment report Where the sponsor so requests, the application for authorisation of a clinical ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 12]] || G || EN || Withdrawal The sponsor may withdraw the application at any time until the reporting date. In such a case, the application may only be withdrawn with respect to all Member States concerned. The ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 13]] || G || EN || Resubmission This Chapter is without prejudice to the possibility for the sponsor to resubmit, following the refusal to grant an authorisation or the withdrawal of an application, an application for ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 14]] || G || EN || Subsequent addition of a Member State concerned 1. Where the sponsor wishes to extend an authorised clinical trial to another Member State (‘additional Member State concerned’), the sponsor shall ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 3 & 4]] || MD || EN || 3. Clinical investigations shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participating in a clinical investigation are protected and ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 70 Paragraph 1]] || MD || EN || Application for clinical investigations 1. The sponsor of a clinical investigation shall submit an application to the Member State(s) in which the clinical investigation is to be conducted (referred ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 70 Paragraph 6 – 7]] || MD || EN || 6. During the period when the application is being assessed, the Member State may request additional information from the sponsor. The expiry of the period laid down in point (b) of paragraph 7 shall ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 73]] || MD || EN || Electronic system on clinical investigations 1. The Commission shall, in collaboration with the Member States, set up, manage and maintain an electronic system: (a) to create the single ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter II Section 1.7]] || MD || EN || DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION For investigational devices covered by Article 62, the sponsor shall draw up and submit the application in accordance with Article ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 57]] || IVD || EN || General requirements regarding performance studies 1. The manufacturer shall ensure that a device for performance study complies with the general safety and performance requirements set out in Annex ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58]] || IVD || EN || Additional requirements for certain performance studies 1. Any performance study: (a) in which surgically invasive sample-taking is done only for the purpose of the performance study; (b) that is an ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 66 Paragraph 1]] || IVD || EN || Application for performance studies 1. The sponsor of a performance study referred to in Article 58(1) and (2) shall enter and submit an application to the Member State(s) in which the performance ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 66 Paragraph 6 – 7]] || IVD || EN || 6. During the period when the application is being assessed the Member State may request additional information from the sponsor. The expiry of the deadline pursuant to the point (b) of paragraph 7 ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 69]] || IVD || EN || Electronic system on performance studies 1. The Commission shall, in collaboration with the Member States, set up, manage and maintain an electronic system: (a) to create the single identification ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter I Section 1.8]] || IVD || EN || DOCUMENTATION REGARDING THE APPLICATION FOR INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND OTHER PERFORMANCE STUDIES INVOLVING RISKS FOR THE SUBJECTS OF THE STUDIES For devices intended to be used ...
|-
| [[Reference:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107m (1)]] || NIS || EN || CHAPTER 4 Supervision of post-authorisation safety studies Article 107m 1. This Chapter applies to non-interventional post-authorisation safety studies which are initiated, managed or financed by the ...
|-
| [[Reference:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107n]] || NIS || EN || Article 107n 1. Before a study is conducted, the marketing authorisation holder shall submit a draft protocol to the Pharmacovigilance Risk Assessment Committee, except for studies to be conducted in ...
|-
| [[Reference:EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22 Article 26]] || NIS || EN || Article 26 1. The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a European medicines web-portal [EU PAS Register] for the dissemination of information ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40]] || G || DE || § 40 Verfahren zur Genehmigung einer klinischen Prüfung (1) Mit der klinischen Prüfung von Arzneimitteln darf nur begonnen werden, wenn die zuständige Bundesoberbehörde die klinische Prüfung nach ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40a]] || G || DE || § 40a Allgemeine Voraussetzungen für die klinische Prüfung [...] Verordnung (EU) Nr. 536/2014 […] Verordnung (EU) Nr. 536/2014 […] Verordnung (EU) Nr. 536/2014 […]
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b-001]] || G || DE || § 40b Besondere Voraussetzungen für die klinische Prüfung [...] Verordnung (EU) Nr. 536/2014 […]
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40c-001]] || G || DE || § 40c Verfahren bei Hinzufügung eines Mitgliedstaates, bei Änderungen sowie bei Bewertungsverfahren (1) Für die Verfahren zur späteren Hinzufügung eines zusätzlichen betroffenen Mitgliedstaates der ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42a]] || G || DE || § 42a Datenschutz Personenbezogene Daten sind vor ihrer Übermittlung nach Artikel 41 Absatz 2 und 4 der Verordnung (EU) Nr. 536/2014 durch den Prüfer oder nach Artikel 42 oder Artikel 53 Absatz 1 der ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 g Absatz 3]] || HM || DE || (3) Nach Beginn einer Studie nach Absatz 1 sind wesentliche Änderungen des Protokolls vor deren Umsetzung, 1. wenn es sich um eine Studie handelt, die nur im Inland durchgeführt wird, von der ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 67 (1) ; (6)]] || HM || DE || § 67 Allgemeine Anzeigepflicht (1) Betriebe und Einrichtungen, die Arzneimittel entwickeln, herstellen, klinisch prüfen, prüfen, lagern, verpacken, einführen, in den Verkehr bringen oder sonst mit ...
|-
| [[Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 6]] || G || DE || § 6 Prüfung der nach Artikel 6 der Verordnung (EU) Nr. 536/2014 in Teil I des Bewertungsberichts zu behandelnden Aspekte (1) Ist die Bundesrepublik Deutschland berichterstattender Mitgliedstaat der ...
|-
| [[Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 7]] || G || DE || § 7 Prüfung der nach Artikel 7 der Verordnung (EU) Nr. 536/2014 in Teil II des Bewertungsberichts zu behandelnden Aspekte (1) Die zuständige Ethik-Kommission kann den Sponsor nach Artikel 7 Absatz 2 ...
|-
| [[Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 10]] || G || DE || § 10 Bewertungsverfahren nach Artikel 44 der Verordnung (EU) Nr. 536/2014 Die zuständige Ethik-Kommission übermittelt ihre Bewertung nach § 40c Absatz 2 des Arzneimittelgesetzes an die zuständige ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 35]] || MD || DE || (2) Soll die klinische Prüfung oder die Leistungsstudie in mehr als einer Prüfstelle durchgeführt werden, bewertet die zuständige Ethik-Kommission den Antrag im Benehmen mit den Ethik-Kommissionen, ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 31]] || MD || DE || § 31 Beginn einer klinischen Prüfung (1) Eine klinische Prüfung von Produkten, die nach den Klassifizierungsregeln des Anhangs VIII Kapitel III der Verordnung (EU) 2017/745 der Klasse I zugeordnet ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 31a]] || IVD || DE || § 31a Beginn einer Leistungsstudie (1) Eine Leistungsstudie, die nach Artikel 58 Absatz 1 Buchstabe a der Verordnung (EU) 2017/746 durchgeführt wird und bei der die Probenahme kein erhebliches ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 31b]] || IVD || DE || § 31b Anzeige von Leistungsstudien mit therapiebegleitenden Diagnostika (1) Leistungsstudien, die therapiebegleitende Diagnostika einbeziehen, bei denen nur Restproben verwendet werden, muss der ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 33]] || MD || DE || § 33 Antrag bei der Ethik-Kommission (1) Die nach Artikel 62 Absatz 4 Buchstabe b der Verordnung (EU) 2017/745 oder Artikel 58 Absatz 5 Buchstabe b der Verordnung (EU) 2017/746 erforderliche ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 38]] || MD || DE || § 38 Antrag (1) Der Antrag nach Artikel 70 Absatz 1 der Verordnung (EU) 2017/745 oder Artikel 66 Absatz 1 der Verordnung (EU) 2017/746 ist vom Sponsor bei der zuständigen Bundesoberbehörde in ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 39]] || MD || DE || § 39 Umfang der Prüfung des Antrags (1) Die zuständige Bundesoberbehörde prüft 1. bei klinischen Prüfungen: den Prüfplan und die erforderlichen Unterlagen nach Maßgabe des Artikels 71 Absatz 1 bis 3 ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 47-002]] || MD || DE || § 47 Anforderungen an sonstige klinische Prüfungen (1) Eine sonstige klinische Prüfung eines Produktes darf auch bei Vorliegen der Voraussetzungen des Artikels 82 Absatz 1 der Verordnung (EU) ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 48]] || MD || DE || § 48 Antrag bei der Ethik-Kommission (1) Die nach Artikel 82 Absatz 1 in Verbindung mit Artikel 62 Absatz 4 Buchstabe b der Verordnung (EU) 2017/745 erforderliche Stellungnahme einer Ethik-Kommission ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 49]] || MD || DE || § 49 Prüfung der Ordnungsmäßigkeit des Antrags durch die Ethik-Kommission (1) Die zuständige Ethik-Kommission prüft, ob der Antrag ordnungsgemäß ist. […]
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 50]] || MD || DE || § 50 Ethische Bewertung der beantragten sonstigen klinischen Prüfung (1) Die zuständige Ethik-Kommission hat die Aufgabe, den Prüfplan und die erforderlichen Unterlagen insbesondere unter ethischen ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 53]] || MD || DE || § 53 Anzeige einer sonstigen klinischen Prüfung bei der zuständigen Bundesoberbehörde (1) Eine sonstige klinische Prüfung ist nach § 47 Absatz 2 Nummer 2 vom Sponsor bei der zuständigen ...
|-
| [[Reference:DEU StrlSchG - Strahlenschutzgesetz 03-Jan-2022 § 32]] || G || DE || § 32 Anzeigebedürftige Anwendung radioaktiver Stoffe oder ionisierender Strahlung am Menschen zum Zweck der medizinischen Forschung (1) Wer beabsichtigt, radioaktive Stoffe oder ionisierende ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63f]] || HM || DE || § 63f Allgemeine Voraussetzungen für nichtinterventionelle Unbedenklichkeitsstudien (1) Nichtinterventionelle Unbedenklichkeitsstudien, die vom Inhaber der Zulassung auf eigene Veranlassung ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63g]] || HM || DE || § 63g Besondere Voraussetzungen für angeordnete nichtinterventionelle Unbedenklichkeitsstudien (1) Der Inhaber der Zulassung hat bei nichtinterventionellen Unbedenklichkeitsstudien, die nach § 28 ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 67 (6)]] || HM || DE || § 67 Allgemeine Anzeigepflicht […] (6) Wer Untersuchungen durchführt, die dazu bestimmt sind, Erkenntnisse bei der Anwendung zugelassener oder registrierter Arzneimittel zu sammeln, hat dies der ...
|-
| [[Reference:DEU SGB V - Sozialgesetzbuch Fünftes Buch 20-Dez-1988 § 35a]] || NIS || DE || § 35a Bewertung des Nutzens von Arzneimitteln mit neuen Wirkstoffen, Verordnungsermächtigung […] (3b) Der Gemeinsame Bundesausschuss kann frühestens mit Wirkung zum Zeitpunkt des erstmaligen ...
|-
| [[Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.3]] || NIS || DE || 1.3. Abgrenzung von nichtinterventionellen Studien gegenüber klinischen Prüfungen Die Landesbehörden sind zuständig für die Einstufung einer Studie als genehmigungspflichtige klinische Prüfung und ...
|-
| [[Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.3]] || NIS || DE || 2. Anwendungsbeobachtungen (AWB) 2.3. Ausnahmen von der Anzeigepflicht nach § 67 Absatz 6 AMG Folgende Studientypen fallen nicht unter den Begriff einer Anwendungsbeobachtung und sind von der ...
|-
| [[Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.2.1 - Ende]] || NIS || DE || 2. Anwendungsbeobachtungen (AWB) 2.2.1. Anzeigeinhalte gegenüber den Bundesoberbehörden [...] Zusätzlich zum Anzeigeformular sind weitere Unterlagen zur Anzeige bei der Bundesoberbehörde ...
|-
| [[Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.2]] || NIS || DE || 2. Anwendungsbeobachtungen (AWB) 2.2. Nationale Anzeigeplicht nach § 67 Absatz 6 AMG [...] Unter die Anzeigeplicht nach § 67 Absatz 6 AMG fällt ebenfalls die „Anwendungsbegleitende Datenerhebung“ ...
|-
| [[Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.5]] || NIS || DE || 2. Anwendungsbeobachtungen (AWB) 2.7.5. Interessenkonflikte, Ethik [...] Es sollte sichergestellt sein, dass vor Durchführung einer Anwendungsbeobachtung eine Beratung durch eine nach Landesrecht ...
|-
| [[Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.2]] || NIS || DE || 3. Nichtinterventionelle Unbedenklichkeitsstudien nach der Zulassung (Postauthorisation safety studies: PASS) 3.2. Nationale Anzeigepflicht nach § 63f AMG [...] Nichtinterventionelle ...
|-
| [[Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.3]] || NIS || DE || 3. Nichtinterventionelle Unbedenklichkeitsstudien nach der Zulassung (Postauthorisation safety studies: PASS) 3.3. Anzeigeninhalte gegenüber den Bundesoberbehörden Die nationale Anzeige an die ...
|-
| [[Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 Article R1123-20]] || G || FR || Article R1123-20 I. – La demande d'avis sur un projet de recherche impliquant la personne humaine est déposée par le promoteur sur le système d'information mentionné à l'article R. 1123-20-1 qui ...
|-
| [[Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 Article R1123-20-1]] || G || FR || Article R1123-20-1 I.-Un système d'information des recherches impliquant la personne humaine permet : 1° Les échanges entre les promoteurs et les comités de protection des personnes. A ce titre, il ...
|-
| [[Reference:FRA SI RIPH 2G - Website 16-May-2025 -]] || MD || FR || Soumission CPP à réaliser via la plateforme centralisée avec tirage au sort du CPP https://siriph.sante.gouv.fr/si-riph-2g/#/login
|-
| [[Reference:FRA AEC-DM-DMDIV_DOC006 v04 AAP_RDM_Partie II_Modalités pratiques 16-May-2025 -]] || MD || FR || Soumission à l'ANSM: E-Mail: EC.DM-COS@ansm-sante.fr
|-
| [[Reference:FRA AEC_DOC010 V.04 01-Jun-2018 -]] || HM || FR || [...] I – DEMANDE D’AUTORISATION D’ESSAI CLINIQUE DE MEDICAMENT AUPRES DE L’ANSM Préambule [...] Préalablement à la mise en place en France d’un essai clinique de médicament, le demandeur doit ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 11 - 12]] || HM || EN || PART 3 AUTHORISATION FOR CLINICAL TRIALS AND ETHICS COMMITTEE OPINION Interpretation of Part 3 11. In this Part— “amendment to the clinical trial authorisation” means an amendment to— (a)the terms of ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 (1)]] || HM || EN || [...] “chief investigator” means— (a)in relation to a clinical trial conducted at a single trial site, the investigator for that site, or (b)in relation to a clinical trial conducted at more than one ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 14]] || HM || EN || Application for ethics committee opinion 14.—(1) An application for an ethics committee opinion in relation to a clinical trial shall be made by the chief investigator for that trial. (2) A chief ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (1) - (6)]] || HM || EN || Application for ethics committee opinion 15.—(1) Subject to paragraphs (3) and (4), an ethics committee shall within the specified period following receipt of a valid application, give an opinion in ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (7) - (10)]] || HM || EN || Application for ethics committee opinion 15.— (7) If— (a)any subject to the clinical trial is to be an adult incapable by reason of physical and mental incapacity to give informed consent to ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 16]] || HM || EN || Review and appeal relating to ethics committee opinion 16.—(1) This regulation applies where a chief investigator for a trial has been notified by the ethics committee to which he made an application ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 17]] || HM || EN || Request for authorisation to conduct a clinical trial 17.—(1) A request for authorisation to conduct a clinical trial shall be made to the licensing authority by the sponsor of the trial. (2) A ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 18]] || HM || EN || Authorisation procedure for clinical trials involving general medicinal products 18.—(1) This regulation applies to clinical trials involving medicinal products other than those to which regulations ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 19 - 20]] || HM || EN || Authorisation procedure for clinical trials involving medicinal products for gene therapy etc. […] Authorisation procedure for clinical trials involving medicinal products with special ...
|-
| [[Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 16 (1) - (3)]] || MD || EN || Procedures for general medical devices for clinical investigationsN.I. 16.—(1) Subject to paragraph (2), no person shall supply a relevant device (if that supply is also a making available of the ...
|-
| [[Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex VIII 1. ; 2.]] || MD || EN || STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES 1.For custom-made devices or for devices intended for clinical investigations the manufacturer or his authorized representative must draw up the ...
|-
| [[Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 1. - 4.]] || MD || EN || Clinical investigation 1. In the case of devices intended for clinical investigations, the manufacturer or the authorised representative, established in the Community, shall follow the procedure ...
|-
| [[Reference:GBR NIHR - National Institute for Health and Care Research 28-Jan-2025 -]] || G || EN || https://www.ct-toolkit.ac.uk/routemap/r-and-d-submission Clinical trials conducted on the premises of an NHS organisation, with NHS patients or with NHS staff, require permission from the local NHS ...
|-
| [[Reference:GBR IRAS - Integrated Research Application System 28-Jan-2025 IRAS]] || G || EN || https://www.myresearchproject.org.uk/ IRAS: Integrated Research Application System ; provides a single gateway for researchers to apply to the new NIHR Coordinated System for gaining NHS Permissions ...
|-
| [[Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.102 (m)]] || G || EN || § 56.102 Definitions. [...] (m) IRB approval means the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set ...
|-
| [[Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.103]] || G || EN || § 56.103 Circumstances in which IRB review is required. (a) Except as provided in §§ 56.104 and 56.105, any clinical investigation which must meet the requirements for prior submission (as required ...
|-
| [[Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.104]] || G || EN || § 56.104 Exemptions from IRB requirement. The following categories of clinical investigations are exempt from the requirements of this part for IRB review: (a) Any investigation which commenced ...
|-
| [[Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.105]] || G || EN || § 56.105 Waiver of IRB requirement. On the application of a sponsor or sponsor-investigator, the Food and Drug Administration may waive any of the requirements contained in these regulations, ...
|-
| [[Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.109]] || G || EN || Subpart C—IRB Functions and Operations [..] § 56.109 IRB review of research. […] (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove ...
|-
| [[Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.111 - §56.112]] || G || EN || § 56.111 Criteria for IRB approval of research. […] § 56.112 Review by institution. Research covered by these regulations that has been approved by an IRB may be subject to further appropriate review ...
|-
| [[Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.124]] || G || EN || § 46.124 Conditions. With respect to any research project or any class of research projects the department or agency head of either the conducting or the supporting Federal department or agency may ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.40 (b)]] || HM || EN || § 312.40 General requirements for use of an investigational new drug in a clinical investigation. […] (b) An IND goes into effect: (1) Thirty days after FDA receives the IND, unless FDA notifies the ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart B]] || MD || EN || Subpart B—Application and Administrative Action § 812.20 Application. (a) Submission. […] (b) Contents […]
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.30]] || MD || EN || § 812.30 FDA action on applications (a) Approval or disapproval. FDA will notify the sponsor in writing of the date it receives an application. FDA may approve an investigation as proposed, approve ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.42]] || MD || EN || § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both approved the application or supplemental application relating to ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart D]] || MD || EN || Subpart D—IRB Review and Approval § 812.60 IRB composition, duties, and functions. An IRB reviewing and approving investigations under this part shall comply with the requirements of part 56 in all ...
|-
| [[Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.4]] || G || EN || § 11.4 To whom does this part apply? […] (c) Determination of responsible party. For purposes of this part, each applicable clinical trial or other clinical trial must have one responsible party. ...
|-
| [[Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.6]] || G || EN || § 11.6 What are the requirements for the submission of truthful information? The clinical trial information submitted by a responsible party under this part shall not be false or misleading in any ...
|-
| [[Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.8]] || G || EN || § 11.8 In what format must clinical trial information be submitted? Information submitted under this part must be submitted electronically to ClinicalTrials.gov, in the format specified at ...
|-
| [[Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.24]] || G || EN || § 11.24 When must clinical trial registration information be submitted? (a) General. Except as provided in paragraph (b) of this section, the responsible party for an applicable clinical trial for ...
|-
| [[Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.64]] || G || EN || § 11.64 When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected? (a) Updates. […] (b) Corrections— […]
|}

=== Module 2: Planning and preparation ===

==== Essential documents ====

===== 2.1.1 — Definition =====
{| class="wikitable"
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| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-001]] || MD || EN || Essential clinical investigation documents [...] Table E.1 - Essential clinical investigation documents prior to clinical investigation [...] Table E.2 - Essential clinical investigation documents ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) Appendix C-001]] || G || EN || Appendix C. ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL C.1 Introduction C.1.1 Many records are generated before and during the conduct of a clinical trial. The nature and extent of those ...
|}

===== 2.1.2 — TMF/ISF =====
{| class="wikitable"
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| [[Reference:ICH ICH E6 Guideline R3 (2025) Appendix C C.2.3]] || G || EN || These essential records should be maintained in or referred to from repositories held by the sponsor and by the investigator/institution for their respective records. These repositories may be ...
|-
| [[Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3]] || G || EN || 3. Trial master file structure and contents 3.1. Sponsor and investigator trial master file The TMF is usually composed of a sponsor TMF, held by the sponsor organisation, and an investigator TMF ...
|-
| [[Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.2]] || G || EN || 3.5.2. Superseded documents During a document’s development (e.g. clinical trial protocol development and release), the sponsor’s/CRO’s procedures may require input and review by various functions. ...
|-
| [[Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.3]] || G || EN || 3.5.3. Correspondence Relevant correspondence that is necessary for reconstruction of key trial conduct activities and decisions should be retained. This includes correspondence with ethics ...
|-
| [[Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 5.1 - 5.2-001]] || G || EN || 5.1. Certified copies A certified copy is a paper or electronic copy of the original document that has been verified (e.g. by a dated signature) or has been generated through a validated process to ...
|-
| [[Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.5]] || HM || EN || 4.5. Trial documentation Content of the Trial Master File (TMF) […] Examples of how risk-adaptation could affect the TMF include the following: - combining of documents: one document serves multiple ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62]] || HM || EN || § 312.62 Investigator recordkeeping and record retention. (a) Disposition of drug. An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.57-001]] || HM || EN || § 312.57 recordkeeping and record retention. (a) A sponsor shall maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug. These records are required ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart G]] || MD || EN || Subpart G—Records and Reports § 812.140 Records. (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the ...
|}

===== 2.1.3 — Clinical Trial Protocol =====
{| class="wikitable"
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| [[Reference:WMA Declaration of Helsinki 2024 Paragraph 22]] || G || EN || Scientific Requirements and Research Protocols [...] 22. The design and performance of all medical research involving human participants must be clearly described and justified in a research ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) Appendix B]] || G || EN || Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) Clinical trials should be described in a clear, concise and operationally feasible protocol. The protocol should be designed in such a ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) II 7.4]] || G || EN || 7.4 Trial processes should be operationally feasible and avoid unnecessary complexity, procedures and data collection. Trial processes should support the key trial objectives. The sponsor should not ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - protocol]] || HM || EN || protocol A document which states the background, rationale and objectives of the trial and describes its design, methodology and organization, including statistical considerations, and the conditions ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 2]] || HM || EN || 2. THE PROTOCOL The clinical trial should be carried out in accordance with a written protocol agreed upon and signed by the investigator and the sponsor. Any change(s) subsequently required must be ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Appendix 2]] || HM || EN || MODEL LIST OF ITEMS TO BE CONTAINED IN A CLINICAL TRIAL PROTOCOL
|-
| [[Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 28-29]] || G || EN || What information should be included in a study protocol?
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - CIP]] || MD || EN || Clinical investigation plan (CIP)
|-
| [[Reference:N.A. SPIRIT 2013 - Chan et al. 2013 -]] || G || EN || SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials Publication: Annals of Internal Medicine ; Volume 158, Number 3 ...
|-
| [[Reference:ICH ICH E8 Guideline R1 (2021) 5.]] || HM || EN || 5. DESIGN ELEMENTS AND DATA SOURCES FOR CLINICAL STUDIES […] Master protocol studies allow for the investigation of multiple drugs or multiple conditions under a shared framework. Platform studies ...
|-
| [[Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Glossary]] || HM || EN || Platform trial Broad - term for a number of clinical trial (CT) designs characterised by a shared framework that allows for the investigation of multiple investigational medicinal products (IMPs) in ...
|-
| [[Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 1.]] || G || EN || ANNEX III Protocols, abstracts and final study reports for post-authorisation safety studies 1. Format of the study protocol [...]
|-
| [[Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) -]] || NIS || EN || [...] VIII.B.3. Study protocol [...] VIII.B.3.1. Format and content of the study protocol [...]
|-
| [[Reference:INT ISPE - GPP Revision 3 (2015) II.]] || INS || EN || II. Protocol Development [...]
|-
| [[Reference:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) 3]] || INS || EN || 3. Development of the study protocol [...]
|-
| [[Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3]] || NIS || DE || Leitlinie 3 (Studienplan und Operationshandbuch) Grundlage einer epidemiologischen Studie ist ein detaillierter und verbindlicher Studienplan, in dem die Studiencharakteristika schriftlich festgelegt ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (6)]] || HM || EN || § 312.23 IND content and format. (a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an “Investigational New Drug Application” (IND) including, in the ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.25]] || MD || EN || § 812.25 Investigational plan. The investigational plan shall include, in the following order: (a) Purpose. The name and intended use of the device and the objectives and duration of the ...
|}

===== 2.1.4 — Investigator’s Brochure =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigator’s Brochure (IB)]] || G || EN || Investigator’s Brochure (IB) A compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human participants ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) Appendix A]] || G || EN || Appendix A. INVESTIGATOR’S BROCHURE
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator’s brochure]] || HM || EN || investigator’s brochure A collection of data for the investigator consisting of all the relevant information on the investigational product(s), including chemical and pharmaceutical data and ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex B]] || MD || EN || Investigator's brochure (IB)
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (5)]] || HM || EN || § 312.23 IND content and format. (a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an “Investigational New Drug Application” (IND) including, in the ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.27]] || MD || EN || § 812.27 Report of prior investigations. (a) General. The report of prior investigations shall include reports of all prior clinical, animal, and laboratory testing of the device and shall be ...
|}

===== 2.1.5 — Other examples of essential documents =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-002]] || MD || EN || Essential clinical investigation documents [...] Table E.1 - Essential clinical investigation documents prior to clinical investigation [...] Table E.2 - Essential clinical investigation documents ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) Appendix C-002]] || G || EN || Appendix C. ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL C.1 Introduction C.1.1 Many records are generated before and during the conduct of a clinical trial. The nature and extent of those ...
|-
| [[Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.10]] || NIS || DE || Leitlinie 3 (Studienplan und Operationshandbuch) [...] Empfehlung 3.10 Ergänzend zum Studienplan sollten in einem Operationshandbuch sämtliche organisatorischen Festlegungen zur Vorbereitung und ...
|}

==== Sponsor ====

===== 2.2.1 — Definitions, responsibilities and tasks =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Contract Research Organisation (CRO)]] || G || EN || Contract Research Organisation (CRO) See Service Provider.
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Service Provider]] || G || EN || Service Provider A person or organisation (commercial, academic or other) providing a service used by either the sponsor or the investigator to fulfil trial-related activities.
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor]] || G || EN || Sponsor An individual, company, institution or organisation that takes responsibility for the initiation, management and arrangement of the financing of a clinical trial. A clinical trial may have ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor-Investigator]] || G || EN || Sponsor-Investigator An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3]] || G || EN || 3. SPONSOR
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - sponsor]] || HM || EN || sponsor An individual, a company, an institution or an organization which takes responsibility for the initiation, management and/or financing of a clinical trial. When an investigator initiates and ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - contract research organization (CRO)]] || HM || EN || contract research organization (CRO) A scientific organization (commercial, academic or other) to which a sponsor may transfer some of its tasks and obligations. Any such transfer should be defined ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.17]] || HM || EN || 4.17 Trials in which the investigator is the sponsor In clinical trials in which the investigator is the sponsor, he or she is responsible for the corresponding functions (see Section 5).
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5]] || HM || EN || 5. RESPONSIBILITIES OF THE SPONSOR
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9]] || MD || EN || [...] 9. Responsibilities of the sponsor [...] 9.3 Outsourcing of duties and functions The sponsor may transfer any or all of the duties and functions related to the clinical investigation, including ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III 2. ; 7.]] || MD || EN || OTHER OBLIGATIONS OF THE SPONSOR [...] 2. The Sponsor shall have an agreement in place to ensure that any serious adverse events or any other event as referred to in Article 80(2) are reported by the ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 2]] || IVD || EN || OTHER OBLIGATIONS OF THE SPONSOR 2. The sponsor shall have an agreement in place to ensure that any serious adverse events or any other event as referred to in Article 76(2) are reported by the ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 24]] || HM || DE || (24) Sponsor ist eine Person, ein Unternehmen, eine Einrichtung oder eine Organisation im Sinne des Artikels 2 Absatz 2 Nummer 14 der Verordnung (EU) Nr. 536/2014.
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b-002]] || HM || DE || § 40b Besondere Voraussetzungen für die klinische Prüfung (6) Die betroffene Person oder, falls diese nicht in der Lage ist, eine Einwilligung nach Aufklärung zu erteilen, ihr gesetzlicher Vertreter ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 3 (1) - (5)]] || HM || EN || Sponsor of a clinical trial 3.—(1) In these Regulations, subject to the following paragraphs, “sponsor” means, in relation to a clinical trial, the person who takes responsibility for the initiation, ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 3 (6) - (11)]] || HM || EN || Sponsor of a clinical trial 3.— (6) After the clinical trial has been authorised by the licensing authority in accordance with regulation 18, 19 or 20, a different person may be specified as ...
|-
| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (e)]] || G || EN || (e) Sponsor means a person who initiates a clinical investigation, but who does not actually conduct the investigation, i.e., the test article is administered or dispensed to or used involving, a ...
|-
| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (f)]] || G || EN || (f) Sponsor-investigator means an individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor]] || HM || EN || [...] Sponsor means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor-Investigator]] || HM || EN || [...] Sponsor-Investigator means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - CRO]] || HM || EN || [...] Contract research organization means a person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.50]] || HM || EN || § 312.50 General responsibilities of sponsors. Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.52]] || HM || EN || § 312.52 Transfer of obligations to a contract research organization. (a) A sponsor may transfer responsibility for any or all of the obligations set forth in this part to a contract research ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53]] || HM || EN || § 312.53 Selecting investigators and monitors. (a) Selecting investigators […] (b) Control of drug. […] (c) Obtaining information from the investigator. [...] (1) A signed investigator statement ...
|-
| [[Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.4 list of investigators]] || G || EN || § 54.4 Certification and disclosure requirements. For purposes of this part, an applicant must submit a list of all clinical investigators who conducted covered clinical studies to determine whether ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (n)]] || MD || EN || (n) Sponsor means a person who initiates, but who does not actually conduct, the investigation, that is, the investigational device is administered, dispensed, or used under the immediate direction ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (o)]] || MD || EN || (o) Sponsor-investigator means an individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.40]] || MD || EN || § 812.40 General responsibilities of sponsors. Sponsors are responsible for selecting qualified investigators and providing them with the information they need to conduct the investigation properly, ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.43]] || MD || EN || § 812.43 Selecting investigators and monitors. (a) Selecting investigators. […] (b) Control of device […] (c) Obtaining agreements [...] curriculum vitae […] investigator's relevant experience […] ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.45]] || MD || EN || § 812.45 Informing investigators. A sponsor shall supply all investigators participating in the investigation with copies of the investigational plan and the report of prior investigations of the ...
|-
| [[Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI C.]] || G || EN || VI. ADDITIONAL STRATEGIES TO ENSURE STUDY QUALITY [...] C. Delegation of Monitoring Responsibilities to a CRO If a sponsor of an IND study delegates the responsibility for ensuring proper monitoring ...
|}

==== Investigators, study sites and resources ====

===== 2.3.1 — Definitions, responsibilities and tasks =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigator]] || G || EN || Investigator A person responsible for the conduct of the clinical trial, including the trial participants for whom that person has responsibility during the conduct of the trial. If a trial is ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2]] || G || EN || 2. INVESTIGATOR 2.1 Qualifications and Training 2.1.1 The investigator(s) should be qualified by education, training and experience to assume responsibility for the proper conduct of the trial and ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sub-Investigator]] || G || EN || Sub-Investigator Any individual member of the clinical trial team designated and under the oversight of the investigator to perform significant trial-related procedures and/or to make important ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator]] || HM || EN || investigator A person responsible for the trial and for the rights, health and welfare of the subjects in the trial. The investigator should have qualifications and competence in accordance with ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - principal investigator]] || HM || EN || principal investigator The investigator serving as coordinator for certain kinds of clinical trials, e.g. multicentre trials.
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 1.4]] || HM || EN || 1.4 Investigator and site(s) of investigation Each investigator should have appropriate expertise, qualifications and competence to undertake a proposed study.Prior to the trial, the investigator(s) ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.2]] || HM || EN || 4.2 Qualifications The investigator should: · have qualifications and competence in accordance with local laws and regulations as evidenced by an up-to-date curriculum vitae and other credentials ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.2]] || MD || EN || 10.2 Qualification of the principal investigator […]
|-
| [[Reference:N.A. Article from Mora et al. 2023 -]] || G || EN || "Clinical research coordinators: Key components of an efficient clinical trial unit" Mora et al., 2023 doi: 10.1016/j.conctc.2023.101057 [...] Although study coordinator figure exists for at least ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 25]] || HM || DE || (25) Prüfer ist eine Person im Sinne des Artikels 2 Absatz 2 Nummer 15 der Verordnung (EU) Nr. 536/2014. Hauptprüfer ist eine Person im Sinne des Artikels 2 Absatz 2 Nummer 16 der Verordnung (EU) Nr. ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 30-001]] || MD || DE || § 30 Prüfer, Hauptprüfer und Leiter einer klinischen Prüfung, Leistungsstudie oder sonstigen klinischen Prüfung (1) Soll eine klinische Prüfung, Leistungsstudie oder sonstige klinische Prüfung von ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 investigator]] || HM || EN || “investigator” means, in relation to a clinical trial, the authorised health professional responsible for the conduct of that trial at a trial site, and if the trial is conducted by a team of ...
|-
| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (d)]] || G || EN || (d) Investigator means an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a ...
|-
| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (h)]] || G || EN || (h) Institution means any public or private entity or agency (including Federal, State, and other agencies). The word facility as used in section 520(g) of the act is deemed to be synonymous with the ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - Investigator]] || HM || EN || Investigator means an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). In the event an ...
|-
| [[Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.4 disclosure]] || G || EN || § 54.4 Certification and disclosure requirements. […] Clinical investigators subject to investigational new drug or investigational device exemption regulations must provide the sponsor of the study ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi)]] || HM || EN || § 312.53 Selecting investigators and monitors. […] (c) […] (vi) A commitment by the investigator that he or she: (a) Will conduct the study(ies) in accordance with the relevant, current protocol(s) ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.60-001]] || HM || EN || § 312.60 General responsibilities of investigators. An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64-001]] || HM || EN || § 312.64 Investigator reports. (a) Progress reports. The investigator shall furnish all reports to the sponsor of the drug who is responsible for collecting and evaluating the results obtained. The ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (e)]] || MD || EN || (e) Institution means a person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (i)]] || MD || EN || (i) Investigator means an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.43 (c) (4)]] || MD || EN || § 812.43 Selecting investigators and monitors. […] (4) A statement of the investigator's commitment to: (i) Conduct the investigation in accordance with the agreement, the investigational plan, this ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart E]] || MD || EN || Subpart E—Responsibilities of Investigators § 812.100 General responsibilities of investigators. An investigator is responsible for ensuring that an investigation is conducted according to the signed ...
|}

===== 2.3.2 — Delegation of activities =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.3]] || G || EN || 2.3 Responsibilities 2.3.1 The investigator may delegate trial-related activities to other persons or parties. The investigator may be supported by the sponsor in the identification of a suitable ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.1]] || MD || EN || 10 Responsibilities of the principal investigator 10.1 General The role of the principal investigator is […]
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.6]] || MD || EN || 7 .6 Additional members of the investigation site team […]
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.1]] || MD || EN || 6 Clinical investigation planning 6.1 General […]
|-
| [[Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Organisation]] || G || EN || Examples of critical and major findings in the sub-categories of the three main categories "General", "Trial Management", and "Investigational Site" are listed below. [...] Organisation and ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 49]] || HM || EN || Suitability of individuals involved in conducting the clinical trial The investigator shall be a medical doctor as defined in national law, or a person following a profession which is recognised in ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-002]] || HM || EN || Compliance with the protocol and good clinical practice The sponsor of a clinical trial and the investigator shall ensure that the clinical trial is conducted in accordance with the protocol and with ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 4]] || MD || EN || 4. A clinical investigation as referred to in paragraph 1 may be conducted only where all of the following conditions are met: (a) the clinical investigation is the subject of an authorisation by the ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72]] || MD || EN || Conduct of a clinical investigation 1. The sponsor and the investigator shall ensure that the clinical investigation is conducted in accordance with the approved clinical investigation plan. 2. In ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68]] || IVD || EN || Conduct of a performance study 1. The sponsor and the investigator shall ensure that the performance study is conducted in accordance with the approved performance study plan. 2. In order to verify ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5-002]] || IVD || EN || 5. A performance study as referred to in paragraph 1 may be conducted only where all of the following conditions are met: (a) the performance study is the subject of an authorisation by the Member ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 7 – 8]] || IVD || EN || 7. The investigator shall be a person exercising a profession which is recognised in the Member State concerned, as qualifying for the role of investigator on account of having the necessary ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 1.12]] || IVD || EN || 1.12. if applicable, information regarding a comparator device, its classification and other information necessary for the identification of the comparator device;
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-001]] || HM || DE || § 40d Besondere Pflichten des Prüfers, des Sponsors und der zuständigen Bundesoberbehörde Bei klinischen Prüfungen mit Arzneimitteln, die aus einem gentechnisch veränderten Organismus oder einer ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 Absatz 5 – 6]] || MD || DE || 5. „Hauptprüfer“ den verantwortlichen Leiter einer Gruppe von Prüfern, die in einer Prüfstelle eine klinische Prüfung oder Leistungsstudie durchführen; 6. „Leiter der klinischen Prüfung“ einen ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 30-002]] || MD || DE || § 30 Prüfer, Hauptprüfer und Leiter einer klinischen Prüfung, Leistungsstudie oder sonstigen klinischen Prüfung (1) Soll eine klinische Prüfung, Leistungsstudie oder sonstige klinische Prüfung von ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-001]] || MD || DE || § 62 Pflichten des Prüfers oder Hauptprüfers (1) Der Prüfer oder Hauptprüfer stellt sicher, dass 1. die klinische Prüfung, die Leistungsstudie oder sonstige klinische Prüfung durchgeführt wird in ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 65]] || MD || DE || § 65 Verarbeitung und Pseudonymisierung personenbezogener Daten [...] (3) Prüfer oder Hauptprüfer müssen vor Übermittlung einer Meldung nach § 63 personenbezogene Daten des Prüfungsteilnehmers unter ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (viii)]] || HM || EN || § 312.53 Selecting investigators and monitors. […] (viii) A list of the names of the subinvestigators (e.g., research fellows, residents) who will be assisting the investigator in the conduct of the ...
|-
| [[Reference:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. A.]] || G || EN || III. CLARIFICATION OF CERTAIN INVESTIGATOR RESPONSIBILITIES This section of the guidance clarifies the investigator’s responsibility to supervise the conduct of the clinical investigation and to ...
|}

===== 2.3.3 — Adequate Resources =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.2]] || G || EN || 2.2 Resources 2.2.1 The investigator should be able to demonstrate (e.g., based on retrospective or currently available data) a potential for recruiting the proposed number of eligible participants ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.7]] || HM || EN || 4.7 Site of the trial, facilities and staff Clinical trials must be carried out under conditions which ensure adequate safety for the subjects. The site selected should be appropriate to the stage of ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.3]] || MD || EN || 10.3 Qualification of investigation site The principal investigator shall be able to demonstrate that the proposed investigation site […]
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 50]] || HM || EN || Suitability of clinical trial sites The facilities where the clinical trial is to be conducted shall be suitable for the conduct of the clinical trial in compliance with the requirements of this ...
|-
| [[Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.9]] || NIS || DE || Leitlinie 3 (Studienplan und Operationshandbuch) [...] Empfehlung 3.9 Für die Auswertungsphase der Studie sind im Studienplan ausreichende zeitliche, personelle und technische Ressourcen einzuplanen. ...
|-
| [[Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.4]] || NIS || DE || Leitlinie 6 (Qualitätssicherung) [...] Empfehlung 6.4 Vor Beginn der Feldarbeit sollen die an der Datenerhebung beteiligten Personen ausführlich geschult, ausgebildet und ihre Tätigkeiten laufend ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (5) (d)]] || HM || EN || Ethics committee opinion 15.— [...] (5) In preparing its opinion, the committee shall consider, in particular, the following matters— (d)the suitability of the investigator and supporting staff;
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1.]] || HM || EN || APPLICATION FOR ETHICS COMMITTEE OPINION 1. An application document including the following information or, in each case, an explanation of why that information is not being provided— […] (t)details ...
|}

===== 2.3.4 — Study Agreement =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.5]] || G || EN || 3.5 Financing The financial aspects of the trial should be documented in an agreement between the sponsor and the investigator/institution.
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Agreement]] || G || EN || Agreement A document or set of documents describing the details of any arrangements on delegation or transfer, distribution and/or sharing of activities and, if appropriate, on financial matters ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.6]] || G || EN || 3.6 Agreements 3.6.1 Agreements made by the sponsor with the investigator/institution, service providers and any other parties (e.g., independent data monitoring committee (IDMC), adjudication ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.14-001]] || G || EN || 3.14 Insurance/Indemnification/Compensation to Participants and Investigators 3.14.1 If required by the applicable regulatory requirement(s), the sponsor should provide insurance or should indemnify ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - contract]] || HM || EN || contract A document, dated and signed by the investigator, institution and sponsor, that sets out any agreements on financial matters and delegation/distribution of responsibilities. The protocol may ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.11]] || HM || EN || 4.11 Financing The relationship between the investigator and the sponsor in matters such as financial support, fees, honorarium payments in kind must be stated in writing in the protocol or contract. ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.9]] || MD || EN || 6.9 Agreement(s) […]
|-
| [[Reference:DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 § 33]] || G || DE || § 33 Zuwendungen bei vertraglicher Zusammenarbeit Soweit Ärztinnen und Ärzte Leistungen für die Hersteller von Arznei- oder Hilfsmitteln oder Medizinprodukten oder die Erbringer von ...
|-
| [[Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.7]] || NIS || DE || 2.7.7. Vergütung und Honorierung Die Beteiligung an einer Anwendungsbeobachtung ist in der Regel eine ärztliche Tätigkeit. Bei Arzneimitteln, die nicht der Verschreibungspflicht oder entsprechenden ...
|-
| [[Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 9]] || NIS || DE || Leitlinie 9 (Vertragliche Rahmenbedingungen) Die Durchführung einer epidemiologischen Studie setzt definierte rechtliche und finanzielle Rahmenbedingungen voraus. Hierzu sind rechtswirksame ...
|-
| [[Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 Article R1121-3-1]] || G || FR || Article R1121-3-1 I.-Lorsqu'une recherche mentionnée au 1° et au 2° de l'article L. 1121-1 à finalité commerciale est réalisée dans des établissements de santé, ou des maisons ou des centres de ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (5) (k)-(l)]] || HM || EN || Ethics committee opinion 15.— [...] (5) In preparing its opinion, the committee shall consider, in particular, the following matters— (k)the amounts, and, where appropriate, the arrangements, for ...
|-
| [[Reference:GBR IRAS - Integrated Research Application System 28-Jan-2025 Templates]] || G || EN || https://www.myresearchproject.org.uk/help/hlptemplatesfor.aspx
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c)]] || HM || EN || § 312.53 Selecting investigators and monitors. (c) Obtaining information from the investigator. Before permitting an investigator to begin participation in an investigation, the sponsor shall obtain ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.43 (c) (5)]] || MD || EN || § 812.43 Selecting investigators and monitors. (c) Obtaining agreements. A sponsor shall obtain from each participating investigator a signed agreement that includes: […] (5) Sufficient accurate ...
|}

==== Medical care of trial subjects ====

=== Module 3: Implementation of the clinical study ===

==== Information and Consent ====

===== 3.1.1 — Informed Consent =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Informed Consent]] || G || EN || Informed Consent A process by which a participant or their legally acceptable representative voluntarily confirms their willingness to participate in a trial after having been informed and been ...
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| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8]] || G || EN || 2.8 Informed Consent of Trial Participants
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| [[Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.2]] || G || EN || 2. INVESTIGATOR [...] 2.2 Informed Consent Considerations [...] 2.2.1 Informed consent may be obtained remotely, where appropriate. When informed consent is obtained remotely, the investigator should ...
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| [[Reference:WMA Declaration of Helsinki 2024 Paragraph 25 – 28]] || G || EN || Free and Informed Consent 25. Free and informed consent is an essential component of respect for individual autonomy. Participation by individuals capable of giving informed consent in medical ...
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| [[Reference:WMA Declaration of Helsinki 2024 Paragraph 31 – 32]] || G || EN || 31. The physician or other researcher must fully inform potential participants which aspects of their care are related to the research. The refusal of a patient to participate in research or the ...
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| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - informed consent]] || HM || EN || informed consent A subject's voluntary confirmation of willingness to participate in a particular trial, and the documentation thereof. This consent should only be sought after all appropriate ...
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| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - witness]] || HM || EN || witness A person who will not be influenced in any way by those who are involved in the clinical trial, who is present and may provide assistance if required when the subject’s informed consent is ...
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| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 c) ; e) - g)]] || HM || EN || 3.3 Informed consent […] c) The subject must have access to information about insurance, if any, and other procedures for compensation and treatment should he or she be injured or disabled by ...
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| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.5]] || HM || EN || 4.5 Information for subjects and informed consent […] Information should be given in both oral and written form in a language understandable to the subject. The protocol should state when and by whom ...
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| [[Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 60-61]] || G || EN || Who may administer informed consent? The person who conducts the consent interview should be knowledgeable about the study and able to answer questions. Some sponsors and some IECs/IRBs require the ...
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| [[Reference:WHO WHO - Guidance for best practices for clinical trials 2024 Annex 2 2.5]] || G || EN || A2.2.5 Protecting research participants Researchers should allocate adequate time and resources for measures and materials to obtain properly informed consent. Consent information should be as ...
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| [[Reference:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 23]] || G || EN || Guideline 4: Individual informed consent [...] Commentary on Guideline 4 [...] Renewing consent. When material changes occur in the conditions or the procedures of a study, and also periodically in ...
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| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.2]] || MD || EN || 5.8.2 Process of obtaining informed consent The principal investigator or his/her authorized designee shall comply with […]
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| [[Reference:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 4.]] || G || EN || 4. Informed consent of trial subjects […] Documentation in the source data of the process of obtaining the initial informed consent and subsequent consent to updates, including paediatric assent and ...
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| [[Reference:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 Page 6]] || G || EN || […] Documentation in the source data of the process of obtaining the initial informed consent and subsequent consent to updates, including paediatric assent and emergency consent, if applicable. […]
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| [[Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex A A5.3]] || G || EN || A5.3 Electronic informed consent Ethics committees will review all material related to the informed consent process. Before the implementation of an electronic consent procedure is considered, the ...
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| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 1]] || HM || EN || General rules 1. A clinical trial may be conducted only where all of the following conditions are met: (a) the anticipated benefits to the subjects or to public health justify the foreseeable risks ...
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| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 2-3]] || HM || EN || 2. Without prejudice to Directive 95/46/EC, the sponsor may ask the subject or, where the subject is not able to give informed consent, his or her legally designated representative at the time when ...
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| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 1]] || HM || EN || Informed consent 1. Informed consent shall be written, dated and signed by the person performing the interview referred to in point (c) of paragraph 2, and by the subject or, where the subject is not ...
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| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 2]] || HM || EN || 2. Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the purposes of obtaining his or her informed consent ...
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| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 3-5]] || HM || EN || 3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give informed consent, his or her legally designated ...
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| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 6-8]] || HM || EN || 6. The subject shall be informed that the summary of the results of the clinical trial and a summary presented in terms understandable to a layperson will be made available in the EU database, ...
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| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 34]] || HM || EN || Additional national measures Member States may maintain additional measures regarding persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial ...
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| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 1]] || MD || EN || Informed consent 1. Informed consent shall be written, dated and signed by the person performing the interview referred to in point (c) of paragraph 2, and by the subject or, where the subject is not ...
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| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 2]] || MD || EN || 2. Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the purposes of obtaining his or her informed consent ...
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| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 3 – 5]] || MD || EN || 3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give informed consent, his or her legally designated ...
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| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 6 – 7]] || MD || EN || 6. The subject shall be informed that a clinical investigation report and a summary presented in terms understandable to the intended user will be made available pursuant to Article 77(5) in the ...
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| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 1]] || IVD || EN || Informed consent 1. Informed consent shall be written, dated and signed by the person performing the interview referred to in point (c) of paragraph 2, and by the subject or, where the subject is not ...
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| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 2]] || IVD || EN || 2. Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the purposes of obtaining his or her informed consent ...
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| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 3 – 5]] || IVD || EN || 3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give informed consent, his or her legally designated ...
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| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 6 – 7]] || IVD || EN || 6. The subject shall be informed that a report of the performance study and a summary presented in terms understandable to the intended user will be made available pursuant to Article 73(5) in the ...
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| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 96 Nr. 10, 11, 21]] || HM || DE || § 96 Strafvorschriften Mit Freiheitsstrafe bis zu einem Jahr oder mit Geldstrafe wird bestraft, wer […] 10. entgegen § 40 Absatz 1 die klinische Prüfung beginnt, 11. entgegen § 40a Satz 1 Nummer 2 ...
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| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 1 – 2]] || MD || DE || § 28 Einwilligung in die Teilnahme (1) Ergänzend zu den Artikeln 63 und 82 Absatz 1 der Verordnung (EU) 2017/745 und Artikel 59 der Verordnung (EU) 2017/746 gelten für die Einwilligung des ...
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| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 3]] || MD || DE || (3) Eine klinische Prüfung, eine Leistungsstudie oder eine sonstige klinische Prüfung mit einer Person, die nicht in der Lage ist, eine Einwilligung nach Aufklärung zu erteilen, darf nur durchgeführt ...
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| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 4 – 6]] || MD || DE || (4) Eine klinische Prüfung, eine Leistungsstudie oder eine sonstige klinische Prüfung darf bei einem Minderjährigen, der in der Lage ist, das Wesen, die Bedeutung und die Tragweite der Prüfung oder ...
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| [[Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.4]] || NIS || DE || 2.7.4. Patientenaufklärung und -einwilligung In der Regel müssen Patienten vor dem Einschluss in eine Anwendungsbeobachtung über die Anwendungsbeobachtung aufgeklärt worden sein und ihre Einwilligung ...
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| [[Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 1 1.2]] || NIS || DE || Leitlinie 1 (Ethik) [...] Empfehlung 1.2 Grundlage jeder epidemiologischen Studie ist die Wahrung der Autonomie der Studienteilnehmerinnen und das Vermeiden von unzumutbaren Risiken. Diese wird in ...
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| [[Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 5]] || NIS || DE || Leitlinie 5 (Probenbanken) In vielen epidemiologischen Studien ist die Anlage einer biologischen Probenbank notwendig bzw. sinnvoll. Hierfür, für die aktuelle und vorgesehene zukünftige Nutzung der ...
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| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 3-001]] || HM || EN || CONDITIONS WHICH APPLY IN RELATION TO AN ADULT ABLE TO CONSENT OR WHO HAS GIVEN CONSENT PRIOR TO THE ONSET OF INCAPACITY 1. The subject has had an interview with the investigator, or another member ...
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| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (g)]] || G || EN || (g) Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.
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| [[Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (e) (1)]] || G || EN || (e) (1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or ...
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| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (p)]] || MD || EN || (p) Subject means a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal ...
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| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (k)-002]] || G || EN || (k) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or ...
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| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (l)]] || G || EN || (l) Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's particpation in the ...
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| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.20]] || G || EN || § 50.20 General requirements for informed consent. Except as provided in §§ 50.22, 50.23, and 50.24, no investigator may involve a human being as a subject in research covered by these regulations ...
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| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.22]] || G || EN || § 50.22 Exception from informed consent requirements for minimal risk clinical investigations. The IRB responsible for the review, approval, and continuing review of the clinical investigation ...
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| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.23]] || G || EN || § 50.23 Exception from general requirements. (a) The obtaining of informed consent shall be deemed feasible unless, before use of the test article (except as provided in paragraph (b) of this ...
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| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.24]] || G || EN || § 50.24 Exception from informed consent requirements for emergency research. […]
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| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.25 (a) - (b)]] || G || EN || § 50.25 Elements of informed consent. (a) Basic elements of informed consent […] (b) Additional elements of informed consent. […]
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| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.27]] || G || EN || § 50.27 Documentation of informed consent. (a) Except as provided in § 56.109(c), informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by ...
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| [[Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.116]] || G || EN || § 46.116 General requirements for informed consent. (a) General. General requirements for informed consent, whether written or oral, […] (b) Basic elements of informed consent […] (c) Additional ...
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| [[Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.117]] || G || EN || § 46.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written informed consent form approved by the ...
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| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (5)]] || MD || EN || § 812.150 Reports. (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: (5) Informed consent. If an investigator uses a device ...
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| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (8)]] || MD || EN || § 812.150 Reports. (b) Sponsor reports [...] (8) Informed consent. A sponsor shall submit to FDA a copy of any report by an investigator under paragraph (a)(5) of this section of use of a device ...
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| [[Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Verification]] || G || EN || IV. RISK-BASED MONITORING […] A. Identify Critical Data and Processes to be Monitored […] • Verification that informed consent was obtained appropriately [...]
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| [[Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Introduction]] || G || EN || II. SUMMARY OF THE CONSENT PROCESS To many, the term informed consent is mistakenly viewed as synonymous with obtaining a subject’s signature on the consent form;9 however, obtaining documentation of ...
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| [[Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-001]] || G || EN || II. SUMMARY OF THE CONSENT PROCESS […] FDA considers advertising used to recruit subjects into the clinical trial to be the start of the ongoing consent process, and the information provided in any ...
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| [[Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 III.]] || G || EN || III. FDA INFORMED CONSENT REQUIREMENTS AND DISCUSSION […] E. Documentation of Informed Consent [...] b. Short Form An IRB may approve a short form to be used in appropriate situations where the ...
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| [[Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 IV.]] || G || EN || IV. RESPONSIBILITIES FOR INFORMED CONSENT […] B. The Clinical Investigator The clinical investigator is responsible for protecting the rights, safety, and welfare of subjects during a clinical ...
|}

===== 3.1.2 — Consent to Data Procesing =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
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| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.1]] || G || EN || 2.9 End of Participation in a Clinical Trial 2.9.1 When a participant decides to stop treatment with the investigational product or withdraw from a trial; is discontinued from the trial; or reaches ...
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| [[Reference:EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 Article 9 Paragraph 1]] || G || EN || Processing of special categories of personal data 1. Processing of personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, ...
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| [[Reference:EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 Article 9 Paragraph 2]] || G || EN || 2. Paragraph 1 shall not apply if one of the following applies: (a) the data subject has given explicit consent to the processing of those personal data for one or more specified purposes, except ...
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| [[Reference:EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 Article 6 Paragraph 1]] || G || EN || Lawfulness of processing 1. Processing shall be lawful only if and to the extent that at least one of the following applies: (a) the data subject has given consent to the processing of his or her ...
|}

===== 3.1.3 — Consent to Data Procesing =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
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| [[Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 4]] || NIS || DE || Leitlinie 4 (Datenschutz) Bei der Planung und Durchführung epidemiologischer Studien ist auf die Einhaltung der geltenden Datenschutzvorschriften und die Gewährleistung der informationellen ...
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| [[Reference:GBR Medicines and Medical Devices Act 2021 21-Feb-2021 Chapter 2 Article 8]] || G || EN || CHAPTER 2 International agreements: disclosure of information 8 Disclosure of information in accordance with international agreements (1)This section applies to information which a relevant authority ...
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| [[Reference:GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020 Article 9 Paragraph 1]] || G || EN || Processing of special categories of personal data 1. Processing of personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, ...
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| [[Reference:GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020 Article 9 Paragraph 2]] || G || EN || 2. Paragraph 1 shall not apply if one of the following applies: (a) the data subject has given explicit consent to the processing of those personal data for one or more specified purposes, except ...
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| [[Reference:GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020 Article 6 Paragraph 1]] || G || EN || Lawfulness of processing 1. Processing shall be lawful only if and to the extent that at least one of the following applies: (a) the data subject has given consent to the processing of his or her ...
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| [[Reference:GBR Data Protection Act 2018 06-Jun-2022 Article 2]] || G || EN || 2 Protection of personal data (1) The [F4UK GDPR] and this Act protect individuals with regard to the processing ofpersonal data, in particular by— (a) requiring personal data to be processed ...
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| [[Reference:GBR Data Protection Act 2018 06-Jun-2022 Schedule 10]] || G || EN || CONDITIONS FOR SENSITIVE PROCESSING UNDER PART 4 Consent to particular processing 1 The data subject has given consent to the processing.Medical purposes [...] 8 (1) The processing is necessary for ...
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| [[Reference:USA 45 CFR Part 160 09-Apr-2025 § 164.508]] || G || EN || § 164.508 Uses and disclosures for which an authorization is required. (a) Standard: Authorizations for uses and disclosures — (1) Authorization required: General rule. Except as otherwise permitted ...
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| [[Reference:USA 45 CFR Part 160 09-Apr-2025 § 164.512]] || G || EN || § 164.512 Uses and disclosures for which an authorization or opportunity to agree or object is not required. Except as provided by § 164.502(a)(5)(iii), a covered entity may use or disclose protected ...
|}

===== 3.1.4 — Special needs and vulnerable population =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
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| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Vulnerable Participants]] || G || EN || Vulnerable Participants Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation ...
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| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.9]] || G || EN || 2.8.9 If a participant or the legally acceptable representative is unable to read, an impartial witness should be present (remotely or in-person) during the entire informed consent discussion. After ...
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| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 1.2.7]] || G || EN || 1.2.7 If minors are to be included in a trial, the IRB/IEC should review the assent information considering the age, maturity and psychological state of the minor population intended to be enrolled, ...
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| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.12]] || G || EN || 2.8.12 Where a minor is to be included as a participant, age-appropriate assent information should be provided and discussed with the minor as part of the consent process, and assent from the minor ...
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| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.13]] || G || EN || 2.8.13 When a clinical trial includes participants who may only be enrolled in the trial with the consent of the participant’s legally acceptable representative, the participants should be informed ...
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| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.8]] || G || EN || 2.8.8 In emergency situations, when prior consent of the participant is not possible, the consent of the participant’s legally acceptable representative, if present, should be requested. When prior ...
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| [[Reference:ICH ICH E6 Guideline R3 (2025) II 2.4]] || G || EN || 2.4 In emergency situations, where consent cannot be obtained prior to trial participation, consent should be obtained from the participant or their legally acceptable representative as soon as ...
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| [[Reference:ICH ICH E21 Concept paper 2023 2.]] || G || EN || E21: Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials Dated 26 May 2023 [...] 2. Background to the proposal and statement of the problem There is an increasing acknowledgement ...
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| [[Reference:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 19]] || G || EN || PREGNANT AND BREASTFEEDING WOMEN AS RESEARCH PARTICIPANTS
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| [[Reference:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 18]] || G || EN || WOMEN AS RESEARCH PARTICIPANTS [...] Vulnerability of women. Despite the current general presumption that favours the inclusion of women in research, in many societies women remain socially ...
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| [[Reference:ICH ICH E11 Guideline R1 (2017) -]] || G || EN || CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION
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| [[Reference:ICH ICH E11 Guideline R1 (2017) 8]] || G || EN || 8. GLOSSARY Parental (legal guardian) consent/permission: Expression of understanding and agreement by fully informed parent(s) or legal guardian to permit the investigator/sponsor of a clinical ...
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| [[Reference:ICH ICH E7 Guideline 1993 -]] || G || EN || STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS
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| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 e) - g)]] || HM || EN || 3.3 Informed consent […] e) Careful consideration should be given to ensuring the freedom of consent obtained from members of a group with a hierarchical structure – such as medical, pharmacy and ...
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| [[Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 22]] || G || EN || [...] In general, all individuals, including healthy volunteers, who participate as research subjects should be viewed as intrinsically vulnerable. When some or all of the subjects, such as children, ...
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| [[Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.1.3]] || G || EN || […] Specific examples of populations that have typically been excluded from clinical trials (either explicitly or by implicit exclusion) include pregnant and lactating women, infants and children, ...
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| [[Reference:WMA Declaration of Helsinki 2024 Paragraph 29 – 30]] || G || EN || 29. When a potential research participant who is incapable of giving free and informed consent is able to give assent to decisions about participation in research, the physician or other qualified ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.55]] || MD || EN || vulnerable subject [..]
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| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.7]] || MD || EN || 5. 7 Vulnerable populations […]
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| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.3]] || MD || EN || 5.8.3 Special circumstances for informed consent 5.8.3.1 General The provisions given in 5.8.3.2 to 5.8.3.4 are subject to national regulations. 5.8.3.2 Subject needing legally designated ...
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| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.4 - 5.8.6]] || MD || EN || 5.8.4 Information to be provided to the subject [...] 5.8.5 Informed consent signature [...] 5.8.6 New information […]
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 31 Paragraph 1]] || HM || EN || Clinical trials on incapacitated subjects 1. In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before the onset of their incapacity, a clinical ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 31 Paragraph 2-3]] || HM || EN || 2. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those clinical trials on incapacitated subjects, where there are no scientific ...
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| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 32 Paragraph 1]] || HM || EN || Clinical trials on minors 1. A clinical trial on minors may be conducted only where, in addition to the conditions set out in Article 28, all of the following conditions are met: (a) the informed ...
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| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 32 Paragraph 2-3]] || HM || EN || 2. The minor shall take part in the informed consent procedure in a way adapted to his or her age and mental maturity. 3. If during a clinical trial the minor reaches the age of legal competence to ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 33]] || HM || EN || Clinical trials on pregnant or breastfeeding women A clinical trial on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set out in Article 28, the following ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 35 Paragraph 1]] || HM || EN || Clinical trials in emergency situations 1. By way of derogation from points (b) and (c) of Article 28(1), from points (a) and (b) of Article 31(1) and from points (a) and (b) of Article 32(1), ...
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| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 35 Paragraph 2-3]] || HM || EN || 2. Following an intervention pursuant to paragraph 1, informed consent in accordance with Article 29 shall be sought to continue the participation of the subject in the clinical trial, and ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 64]] || MD || EN || Clinical investigations on incapacitated subjects 1. In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before the onset of their incapacity, a ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 65]] || MD || EN || Clinical investigations on minors A clinical investigation on minors may be conducted only where, in addition to the conditions set out in Article 62(4), all of the following conditions are met: (a) ...
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| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 66]] || MD || EN || Clinical investigations on pregnant or breastfeeding women A clinical investigation on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set out in Article ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 68]] || MD || EN || Clinical investigations in emergency situations 1. By way of derogation from point (f) of Article 62(4), from points (a) and (b) of Article 64(1) and from points (a) and (b) of Article 65, informed ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 1]] || HM || DE || § 40b Besondere Voraussetzungen für die klinische Prüfung (1) Ergänzend zu Artikel 29 der Verordnung (EU) Nr. 536/2014 gelten für die Einwilligung der betroffenen Person oder, falls diese nicht in ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 2]] || HM || DE || (2) Die betroffene Person oder, falls diese nicht in der Lage ist, eine Einwilligung nach Aufklärung zu erteilen, ihr gesetzlicher Vertreter ist durch einen Prüfer, der Arzt oder, bei einer ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 3]] || HM || DE || (3) Eine klinische Prüfung darf bei einem Minderjährigen, der in der Lage ist, das Wesen, die Bedeutung und die Tragweite der klinischen Prüfung zu erkennen und seinen Willen hiernach auszurichten, ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 4]] || HM || DE || (4) Eine klinische Prüfung mit einer Person, die nicht in der Lage ist, Wesen, Bedeutung und Tragweite der klinischen Prüfung zu erkennen und ihren Willen hiernach auszurichten, darf nur durchgeführt ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 5]] || HM || DE || (5) Eine klinische Prüfung darf in Notfällen nur durchgeführt werden, wenn die Voraussetzungen des Artikels 35 der Verordnung (EU) Nr. 536/2014 vorliegen.
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 6-001]] || HM || DE || (6) Die betroffene Person oder, falls diese nicht in der Lage ist, eine Einwilligung nach Aufklärung zu erteilen, ihr gesetzlicher Vertreter muss ausdrücklich und entweder schriftlich oder ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41]] || HM || DE || § 41 Stellungnahme der Ethik-Kommission (1) Die Stellungnahme der Ethik-Kommission nach § 40 Absatz 4 Satz 2 muss ein klares Votum im Sinne einer Zustimmung, einer Zustimmung mit Auflagen im Sinne ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 3-002]] || HM || EN || PART 3 CONDITIONS WHICH APPLY IN RELATION TO AN ADULT ABLE TO CONSENT OR WHO HAS GIVEN CONSENT PRIOR TO THE ONSET OF INCAPACITY 1. The subject has had an interview with the investigator, or another ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 4]] || HM || EN || CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO A MINOR Conditions 1. Subject to paragraph 6, a person with parental responsibility for the minor or, if by reason of the emergency nature of the ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 5]] || HM || EN || CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO AN INCAPACITATED ADULT Conditions 1. The subject’s legal representative has had an interview with the investigator, or another member of the ...
|-
| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (m)]] || G || EN || (m) Family member means any one of the following legally competent persons: Spouse; parents; children (including adopted children); brothers, sisters, and spouses of brothers and sisters; and any ...
|-
| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (n)]] || G || EN || (n) Assent means a child's affirmative agreement to participate in a clinical investigation. Mere failure to object should not, absent affirmative agreement, be construed as assent.
|-
| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (o)]] || G || EN || (o) Children means persons who have not attained the legal age for consent to treatments or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the ...
|-
| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (p)]] || G || EN || (p) Parent means a child's biological or adoptive parent.
|-
| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (q)]] || G || EN || (q) Ward means a child who is placed in the legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State, or local law.
|-
| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (r)]] || G || EN || (r) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in a clinical investigation.
|-
| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (s)]] || G || EN || (s) Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.
|-
| [[Reference:USA 21 CFR Part 50 09-Apr-2025 Subpart D]] || G || EN || Subpart D—Additional Safeguards for Children in Clinical Investigations […] § 50.50 IRB duties. […] § 50.51 Clinical investigations not involving greater than minimal risk. […] § 50.52 Clinical ...
|-
| [[Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart B]] || G || EN || Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research […] § 46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and ...
|-
| [[Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart C]] || G || EN || Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects […] § 46.303 Definitions. […] (c) Prisoner means any individual involuntarily ...
|-
| [[Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart D]] || G || EN || Subpart D—Additional Protections for Children Involved as Subjects in Research […] § 46.402 Definitions. The definitions in § 46.102 of the pre-2018 Requirements and the 2018 Requirements, as ...
|-
| [[Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 V.]] || G || EN || V. FREQUENTLY ASKED QUESTIONS […] 1. What are some considerations for enrolling a child into a clinical investigation? [...] 2. Are there any additional protections required when enrolling children ...
|}

==== Recruitment, screening and eligibility ====

===== 3.2.1 — Recruitment strategies and materials =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.4.2]] || G || EN || 2.4 Communication with IRB/IEC [...] 2.4.2Before initiating a trial, the investigator/institution should have a documented and dated approval/favourable opinion from the IRB/IEC for the trial ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.3]] || HM || EN || 4.3 Selection of trial subjects The investigator is responsible for ensuring the unbiased selection and an adequate number of suitable subjects according to the protocol. It may be necessary to ...
|-
| [[Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 44]] || G || EN || What about financial reimbursements to research subjects? Financial reimbursements to subjects are distinct from any benefi ts contributing to the risk-benefi t analysis. Where applicable laws and ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - recruitment]] || MD || EN || recruitment […]
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section K No. 59-60]] || HM || EN || RECRUITMENT ARRANGEMENTS (INFORMATION PER MEMBER STATE CONCERNED) 59. Unless described in the protocol, a separate document shall describe in detail the procedures for inclusion of subjects and shall ...
|-
| [[Reference:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.9]] || G || EN || 2.9. Recruitment and consent Points to consider: • Recruitment strategies. • Volunteer database. • Collection and verification of the trial participants medical history. • Contact with the trial ...
|-
| [[Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Q5.2]] || HM || EN || Q5.2: How to integrate pre-screening and screening processes for biomarkers within the shared framework of CCTs? […] There might also be situations when potential participants with a particular ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40 Absatz 2]] || G || DE || § 40 Verfahren zur Genehmigung einer klinischen Prüfung (2) Der nach Artikel 5 Absatz 1 der Verordnung (EU) Nr. 536/2014 zu stellende Antrag auf Genehmigung einer klinischen Prüfung ist über das ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 33 Absatz 2]] || MD || DE || (2) Der Antrag muss enthalten: [...] Unterlagen, die für den Prüfungsteilnehmer oder seinen gesetzlichen oder rechtsgeschäftlichen Vertreter bestimmt sind, sowie die Zusammenfassung des klinischen ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. ; 3.]] || HM || EN || PARTICULARS AND DOCUMENTS THAT MUST ACCOMPANY AN APPLICATION FOR AN ETHICS COMMITTEE OPINION, A REQUEST FOR AUTHORISATION, A NOTICE OF AMENDMENT AND A NOTIFICATION OF THE CONCLUSION OF A TRIAL PART 1 ...
|-
| [[Reference:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 -]] || HM || EN || FDA requires that an Institutional Review Board (IRB) review and have authority to approve, requiremodifications in, or disapprove all research activities covered by the IRB regulations [21 ...
|-
| [[Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-002]] || G || EN || II. SUMMARY OF THE CONSENT PROCESS […] FDA considers advertising used to recruit subjects into the clinical trial to be the start of the ongoing consent process, and the information provided in any ...
|}

===== 3.2.2 — Screening and eligibility =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E8 Guideline R1 (2021) 5.1]] || G || EN || Study Population The population to be studied should be chosen to support the study objectives and is defined through the inclusion and exclusion criteria for the study The degree to which a study ...
|-
| [[Reference:ICH ICH E8 Guideline R1 (2021) 7]] || G || EN || Consideration in identifying critical to quality factors […] The eligibility criteria should be reflective of the study objectives and be well documented in the clinical study protocol. […]
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 5]] || G || EN || B.5 Selection of Participants B.5.1 Participant inclusion criteria. B.5.2 Participant exclusion criteria. B.5.3 Mechanism for pre-screening, where appropriate, and screening of participants.
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-001]] || G || EN || B.6 Discontinuation of Trial Intervention and Participant Withdrawal from Trial The investigator may choose to discontinue the participant from the trial. Conversely, the participant may decide to ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.5]] || MD || EN || A.5 Objectives and hypotheses of the clinical investigation [...] The objectives of the clinical investigation shall […]
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-001]] || MD || EN || A.6.3 Subjects a) Inclusion […]
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. (i)]] || HM || EN || 1. An application document including the following information or, in each case, an explanation of why that information is not being provided— […] (i)the criteria for inclusion and exclusion of ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (c) - (d)]] || HM || EN || § 312.23 IND content and format. […] (6) Protocols. [...] (c) The criteria for patient selection and for exclusion of patients and an estimate of the number of patients to be studied. (d) A ...
|-
| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 812.36 (c)]] || G || EN || § 812.36 Treatment use of an investigational device. (c) Applications for treatment use. (1) A treatment IDE application shall include, in the following order: [...] (ii) The intended use of the ...
|-
| [[Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Adherence]] || G || EN || IV. RISK-BASED MONITORING […] A. Identify Critical Data and Processes to be Monitored […] • Adherence to protocol eligibility criteria designed to exclude individuals for whom the investigational ...
|}

==== Randomisation and Unblinding ====

===== 3.3.1 — Definitions =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Blinding/Masking]] || G || EN || Blinding/Masking A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the participant(s) being unaware, and ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Randomisation]] || G || EN || Randomisation The process of deliberately including an element of chance when assigning participants to groups that receive different treatments in order to reduce bias.
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.11]] || G || EN || 2.11Randomisation Procedures and Unblinding The investigator should follow the trial’s randomisation procedures, if any, and, in the case of an investigator-blinded trial, should ensure that the ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.15]] || G || EN || 3.15 Investigational Product(s) [...] (d) In blinded trials, the sponsor should implement: (i) A process to blind individuals, including the sponsor staff, trial participant, investigator and/or ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.3]] || G || EN || 2.9 End of Participation in a Clinical Trial [...] 2.9.3 Where relevant, the investigator should inform the participant about the trial results and treatment received when this information is ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 (g)]] || G || EN || 3.16.1 Data Handling [...] (g) Procedures should be in place to describe unblinding; where applicable; these descriptions should include: (i) who were unblinded, at what timepoint and for what ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.1]] || G || EN || 4.1Safeguard Blinding in Data Governance 4.1.1 Maintaining the integrity of the blinding is important in particular in the design of systems, management of users’ accounts, delegation of ...
|-
| [[Reference:ICH ICH E8 Guideline R1 (2021) 5.6]] || HM || EN || 5.6 Statistical Analysis […] For double-blind studies, the statistical analysis should be finalised before treatment assignments are revealed. Therefore, if a study includes one or more interim ...
|-
| [[Reference:ICH ICH E9 Guideline 1998 2.3]] || HM || EN || 2.3 Design Techniques to Avoid Bias The most important design techniques for avoiding bias in clinical trials are blinding and randomisation, and these should be normal features of most controlled ...
|-
| [[Reference:ICH ICH E9 Guideline 1998 2.3.1]] || HM || EN || [...] Breaking the blind (for a single subject) should be considered only when knowledge of the treatment assignment is deemed essential by the subject’s physician for the subject’s care. Any ...
|-
| [[Reference:ICH ICH E9 Guideline 1998 Glossary - Double-Dummy]] || HM || EN || Double-Dummy A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical. Supplies are prepared for Treatment A (active and ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.2]] || HM || EN || 9.2 Randomization and blinding In case of a randomized clinical trial, the randomization procedure must be documented. Where a sealed code for each individual treatment has been supplied in a ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Introduction]] || HM || EN || 8. RECORD KEEPING AND HANDLING OF DATA [...] A basic aspect of the integrity of data is the safeguarding of “blinding” with regard to treatment assignment. It starts with the randomization of ...
|-
| [[Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 31]] || G || EN || When is unblinding of the trial by the investigator permissible? How should unblinding be accomplished (in those situations where it would be allowed)? Unblinding may be necessary in the event of a ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.5]] || MD || EN || blinding masking […]
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - randomization]] || MD || EN || randomization […]
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.7 (e)]] || MD || EN || [...] e) provide the subject with [...]
|}

===== 3.3.2 — Requirements =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No.17 ; No. 22]] || HM || EN || PROTOCOL [...] 17. The protocol shall at least include: [...] (m) a description of the measures taken to minimise bias, including, if applicable, randomisation and blinding; [...] 22. Issues ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section D No. 8]] || HM || EN || REPLACING OF INFORMATION 8. The particulars listed in sections A, B and C, other than those particulars listed in paragraph 9, may be omitted from the label of a product and made available by other ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section 2.5 No. 17-22]] || HM || EN || Unblinding treatment allocation 17. The investigator shall only unblind the treatment allocation of a subject in the course of a clinical trial if unblinding is relevant to the safety of the subject. ...
|-
| [[Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex 5 A5.2]] || G || EN || Annex 5 Additional consideration to specific systems [...] A5.2 Interactive response technology system [...] A5.2.1.2 Stratified randomisation Where the randomisation is stratified by factors ...
|-
| [[Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Randomisation]] || G || EN || Examples of critical and major findings in the sub-categories of the three main categories "General", "Trial Management", and "Investigational Site" are listed below. [...] ...
|-
| [[Reference:USA 21 CFR Part 314 09-Apr-2025 § 314.126 (4) - (5)]] || HM || EN || § 314.126 Adequate and well-controlled studies. [...] (4) The method of assigning patients to treatment and control groups minimizes bias and is intended to assure comparability of the groups with ...
|-
| [[Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.10 (b) (5)]] || G || EN || (5) Study Design means a description of the manner in which the clinical trial will be conducted, including the following information: (i) Interventional Study Model. The strategy for assigning ...
|-
| [[Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Conduct]] || G || EN || IV. RISK-BASED MONITORING […] A. Identify Critical Data and Processes to be Monitored […] • Conduct and documentation of procedures essential to trial integrity, such as ensuring the study blind is ...
|}

==== Investigational Product/Device ====

===== 3.4.1 — Definitions =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigational Product]] || G || EN || Investigational Product A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorisation when used ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Comparator]] || G || EN || Comparator An investigational or authorised medicinal product (i.e., active control), placebo or standard of care used as a reference in a clinical trial.
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigational product (synonym: study product)]] || HM || EN || investigational product (synonym: study product) Any pharmaceutical product (see definition) or placebo being tested or used as a reference in a clinical trial. study product (synonym: ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - comparator product]] || HM || EN || comparator product A pharmaceutical or other product (which may be a placebo) used as a reference in a clinical trial.
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.29]] || MD || EN || investigational medical device […]
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.12]] || MD || EN || comparator […]
|}

===== 3.4.2 — Responsibilities =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.10]] || G || EN || 2.10 Investigational Product Management 2.10.1 Responsibility for investigational product(s) management, including accountability, handling, dispensing, administration and return, rests with the ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4.5.3]] || G || EN || 3.11.4.5.3 Monitoring of Investigational Product Management (a) Confirming, for the investigational product(s): (i) That storage conditions are acceptable and in accordance with the storage ...
|-
| [[Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3]] || G || EN || 2.3 Investigational Product Management Various approaches to investigational product management (i.e., supply, storage, dispensing, administration, return, accountability documentation, destruction ...
|-
| [[Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3.2]] || G || EN || 2.3.2 Certain documentation and processes already used in the institution/healthcare centre may be sufficient for the management of the investigational product, in accordance with local regulatory ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.6]] || HM || EN || 5.6 Investigational product The sponsor is responsible for supplying the investigational pharmaceutical product(s) and, if applicable, comparator products, prepared in accordance with principles of ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.3]] || HM || EN || 10.3 Responsibilities of the investigator The investigator is responsible for ensuring: · Proper and safe handling of the investigational and, when appropriate, comparator products during and after ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.4]] || HM || EN || 10.4 Responsibilities of the sponsor and monitor (see also Sections 5 and 6) The sponsor is responsible for: · Supplying the investigational and, when appropriate, comparator product(s), prepared in ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-002]] || MD || EN || medical device […]
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.9]] || MD || EN || 7.9 Investigational device accountability […]
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-001]] || MD || EN || 7.4.3 Device deficiencies […]
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 51]] || HM || EN || Traceability, storage, return and destruction of investigational medicinal products 1. Investigational medicinal products shall be traceable. They shall be stored, returned and/or destroyed as ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 66]] || HM || EN || Unauthorised investigational and unauthorised auxiliary medicinal products 1. The following information shall appear on the outer packaging and on the immediate packaging of unauthorised ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 67]] || HM || EN || Authorised investigational and authorised auxiliary medicinal products 1. Authorised investigational medicinal products and authorised auxiliary medicinal products shall be labelled: (a) in ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 68]] || HM || EN || Radiopharmaceuticals used as investigational medicinal products or as auxiliary medicinal products for a medical diagnosis Articles 66 and 67 shall not apply to radiopharmaceuticals used as ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 69]] || HM || EN || Language The language of the information on the label shall be determined by the Member State concerned. The medicinal product may be labelled in several languages.
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 investigational medicinal product]] || HM || EN || “investigational medicinal product” means a pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a clinical trial, and ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 7 Part 2 2.]] || HM || EN || PROVISIONS WHICH MAY BE INCORPORATED IN AN AUTHORISATION RELATING TO THE MANUFACTURE OR ASSEMBLY OF INVESTIGATIONAL MEDICINAL PRODUCTS [...] 2. The holder of the authorisation shall— (a)provide and ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 12.]] || HM || EN || CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS Principles based on International Conference on Harmonisation GCP Guideline [...] 12. Investigational medicinal products used in the trial ...
|-
| [[Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (j)]] || G || EN || (j) Test article means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (g)]] || MD || EN || (g) Investigational device means a device, including a transitional device, that is the object of an investigation.
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (m)]] || MD || EN || (m) Significant risk device means an investigational device that: (1) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; (2) Is ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (r)]] || MD || EN || (r) Transitional device means a device subject to section 520(l) of the act, that is, a device that FDA considered to be a new drug or an antibiotic drug before May 28, 1976.
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.6 - §312.8 ; § 312.10]] || HM || EN || […] § 312.6 Labeling of an investigational new drug. […] § 312.7 Promotion of investigational drugs. […] § 312.8 Charging for investigational drugs under an IND. […] § 312.10 Waivers. […]
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.40 (c) (d)]] || HM || EN || § 312.40 General requirements for use of an investigational new drug in a clinical investigation. […] (c) A sponsor may ship an investigational new drug to investigators named in the IND: (1) Thirty ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (b)]] || HM || EN || § 312.53 Selecting investigators and monitors. […] (b) Control of drug. A sponsor shall ship investigational new drugs only to investigators participating in the investigation. […]
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.61]] || HM || EN || § 312.61 Control of the investigational drug. An investigator shall administer the drug only to subjects under the investigator's personal supervision or under the supervision of a subinvestigator ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (a)]] || HM || EN || § 312.62 Investigator recordkeeping and record retention. (a) Disposition of drug. An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.69]] || HM || EN || § 312.69 Handling of controlled substances. If the investigational drug is subject to the Controlled Substances Act, the investigator shall take adequate precautions, including storage of the ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.110 (c)]] || MD || EN || § 812.110 Specific responsibilities of investigators. (c) Supervising device use. An investigator shall permit an investigational device to be used only with subjects under the investigator's ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (2)]] || MD || EN || § 812.140 Records. […] (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator's participation in an ...
|}

=== Module 4: Study course and documentation ===

==== Compliance ====

===== 4.1.1 — Compliance with Protocol =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Compliance (in relation to trials)]] || G || EN || Compliance (in relation to trials) Adherence to the trial-related requirements, GCP requirements and the applicable regulatory requirements.
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.5]] || G || EN || 2.5 Compliance with Protocol 2.5.1The investigator/institution should sign the protocol or an alternative contract to confirm agreement with the sponsor. 2.5.2The investigator should comply with the ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 2.5]] || G || EN || Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) [...] B.2.5 A statement that the trial will be conducted in compliance with the protocol, Good Clinical Practice (GCP) and the applicable ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Introduction]] || HM || EN || 4.4 Compliance with the protocol The investigator must agree and sign the protocol ( or another legally acceptable document mentioning the agreement with the protocol) with the sponsor, and confirm ...
|-
| [[Reference:WHO WHO - Guidance for best practices for clinical trials 2024 3.2.4]] || G || EN || 3.2.4 Training and mentoring Investment in education and training is required in all regions through accessible (practically and financially) fit-for-purpose training packages. There is a need to ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.6]] || MD || EN || 10.6 Compliance with the CIP The principal investigator shall […]
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-003]] || HM || EN || Compliance with the protocol and good clinical practice The sponsor of a clinical trial and the investigator shall ensure that the clinical trial is conducted in accordance with the protocol and with ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 6.]] || HM || EN || CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS Principles based on International Conference on Harmonisation GCP Guideline [...] 6. A trial shall be conducted in compliance with the ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) - (vii)]] || HM || EN || § 312.53 Selecting investigators and monitors. […] (c) […] (vi) A commitment by the investigator that he or she: (a) Will conduct the study(ies) in accordance with the relevant, current protocol(s) ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (a)]] || MD || EN || § 812.46 Monitoring investigations (a) Securing compliance. A sponsor who discovers that an investigator is not complying with the signed agreement, the investigational plan, the requirements of this ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.110 (b)]] || MD || EN || § 812.110 Specific responsibilities of investigators. (b) Compliance. An investigator shall conduct an investigation in accordance with the signed agreement with the sponsor, the investigational ...
|}

===== 4.1.2 — Noncompliance =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.12]] || G || EN || 3.12 Noncompliance 3.12.1 Noncompliance with the protocol, SOPs, GCP and/or applicable regulatory requirement(s) by an investigator/institution or by member(s) of the sponsor’s staff should lead to ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 12.3]] || G || EN || Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) [...] B.12.3 Description of the process for the handling of non-compliance with the protocol or GCP.
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.70]] || HM || EN || § 312.70 Disqualification of a clinical investigator. […]
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.119]] || MD || EN || § 812.119 Disqualification of a clinical investigator. […]
|}

===== 4.1.3 — Findings =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9.3]] || G || EN || 3.9.3 The sponsor should determine necessary trial-specific criteria for classifying protocol deviations as important. Important protocol deviations are a subset of protocol deviations that may ...
|-
| [[Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - ComCompliance]] || G || EN || Examples of critical and major findings in the sub-categories of the three main categories "General", "Trial Management", and "Investigational Site" are listed below. [...] Investigational Site ...
|-
| [[Reference:GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015 -]] || HM || EN || Inspection findings At the end of the inspection the inspector will give you a verbal summary of the inspection findings and allow you the opportunity to correct any misunderstandings.The grading of ...
|}

===== 4.1.4 — Serious breaches =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 52]] || HM || EN || Reporting of serious breaches 1. The sponsor shall notify the Member States concerned about a serious breach of this Regulation or of the version of the protocol applicable at the time of the breach ...
|-
| [[Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.1]] || G || EN || 3. How to report a serious breach 3.1. Who should notify The sponsor is responsible for the notification via the EU portal and EU database - part of the Clinical Trials Information System (CTIS). The ...
|-
| [[Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 6.4]] || G || EN || 6.4. Principal Investigator The principal investigator should have a process in place to ensure that: • the site staff or service providers delegated by the principal investigator/institution are ...
|-
| [[Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.2]] || G || EN || 3.2. When should the notification be made? Without undue delay and at the latest within 7 calendar days of the sponsor becoming aware of a serious breach. If the sponsor has reasonable grounds based ...
|-
| [[Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 5.1]] || G || EN || 5.1. What needs to be reported? Any breach of: • The Regulation (EU) No 536/2014. or • The clinical trial protocol version applicable at the time of the breach. which is likely to affect to a ...
|-
| [[Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 4]] || G || EN || 4. Clarification on reporting requirements • Serious breaches which occurred outside the EU/EEA while the application for a clinical trial authorisation (CTA) is submitted but not yet authorised in ...
|-
| [[Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 Appendix I]] || G || EN || Appendix I – Examples of serious breaches
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 29A]] || HM || EN || 29A. (1) The sponsor of a clinical trial shall notify the licensing authority in writing of any serious breach of - (a) the conditions and principles of GCP in connection with that trial; or (b) the ...
|-
| [[Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Who should notify]] || HM || EN || D. Arrangements for notification Who should notify? The Sponsor or a person legally authorised by the Sponsor to perform this function (for example, a legal representative or contract research ...
|-
| [[Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Investigator/Institution]] || HM || EN || [...] Investigator/Institution: The investigator/institution (for example, vendor, CRO or investigator site) should also have a process in place to identify and notify the sponsor of serious ...
|-
| [[Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D When should the notification be made]] || HM || EN || […] When should the notification be made? • Within 7 days of the Sponsor becoming aware of the breach. If the notification function has been delegated by the Sponsor to another party, for example, a ...
|-
| [[Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D What needs to be reported]] || HM || EN || What needs to be reported? • Any serious breach of: (a) The conditions and principles of good clinical practice in connection with that trial (as defined in UK legislation); or (b) The protocol ...
|-
| [[Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix I]] || HM || EN || [...] 6. For trials that are on-going in the UK, should serious breaches that occur at non-UK sites be reported? If a serious breach is identified at an investigator site outside the UK that has a ...
|-
| [[Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix II]] || HM || EN || Appendix II Examples of Serious Breaches Notified to MHRA (this is not an exhaustive list)
|}

==== Source Data and CRF ====

===== 4.2.1 — Source Records =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Data Integrity]] || G || EN || Data Integrity Data integrity includes the degree to which data fulfil key criteria of being attributable, legible, contemporaneous, original, accurate, complete, secure and reliable such that data ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Source Records]] || G || EN || Source Records Original documents or data (which includes relevant metadata) or certified copies of the original documents or data, irrespective of the media used. This may include trial ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Metadata]] || G || EN || Metadata The contextual information required to understand a given data element. Metadata is structured information that describes, explains or otherwise makes it easier to retrieve, use or manage ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Certified Copy]] || G || EN || Certified Copy A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.1 - 2.12.3]] || G || EN || 2.12 Records 2.12.1 In generating, recording and reporting trial data, the investigator should ensure the integrity of data under their responsibility, irrespective of the media used. 2.12.2 The ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.5 – 2.12.9]] || G || EN || 2.12.5 The investigator should ensure the accuracy, completeness, legibility and timeliness of the data reported to the sponsor in the data acquisition tools completed by the investigator site (e.g., ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.11 – 2.12.14]] || G || EN || 2.12.11 The investigator/institution should maintain the trial records as specified in Appendix C and as required by the applicable regulatory requirement(s). The investigator/institution should have ...
|-
| [[Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 Introduction]] || G || EN || [...] Data may be broadly classified into two types, and a trial may make use of both types of data (i.e., data generated specifically for the trial (primary data collection) or data obtained from ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - patient/subject file]] || HM || EN || patient/subject file A collection of data consisting of all relevant information on the patient or subject (such as hospital file, consultation records or special subject file) that permits the ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - raw data]] || HM || EN || raw data All records or certified copies of original observations, clinical findings or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Such ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8]] || HM || EN || 8. RECORD KEEPING AND HANDLING OF DATA […] All steps involved in data management should be documented in order to allow step-by-step retrospective assessment of quality of the data and the ...
|-
| [[Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 94]] || G || EN || [...] What is meant by “data quality”? What is meant by “data integrity”? How are the terms related, and how are data quality and integrity achieved within GCP? “Data quality” refers to the essential ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.47]] || MD || EN || source data […]
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.48]] || MD || EN || source document […]
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.5.3]] || MD || EN || 7.5.3 Source documents […]
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.8]] || MD || EN || 7.8.1 Traceability of documents and data [….]
|-
| [[Reference:WMA Declaration of Helsinki 2024 Paragraph 17]] || G || EN || 17. All medical research involving human participants must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with ...
|-
| [[Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 5.1 - 5.2-002]] || G || EN || 5.1. Certified copies A certified copy is a paper or electronic copy of the original document that has been verified (e.g. by a dated signature) or has been generated through a validated process to ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-002]] || MD || DE || § 62 Pflichten des Prüfers oder Hauptprüfers (1) Der Prüfer oder Hauptprüfer stellt sicher, dass 1. die klinische Prüfung, die Leistungsstudie oder sonstige klinische Prüfung durchgeführt wird in ...
|-
| [[Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-002]] || NIS || DE || 1. Nichtinterventionelle Studien (NIS) 1.1. Definition einer nichtinterventionellen Studie [...] Dokumentationssystematisierende und den Arzt-Patienten-Dialog strukturierende Fragebögen können als ...
|-
| [[Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.7]] || NIS || DE || Leitlinie 3 (Studienplan und Operationshandbuch) [...] Empfehlung 3.7 Alle verwendeten Datenquellen sind im Studienplan zu nennen. [...]
|-
| [[Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 7]] || NIS || DE || Leitlinie 7 (Datenhaltung und –dokumentation) Für die Erfassung und Haltung aller während der Studie erhobenen Daten sowie für die Aufbereitung, Plausibilitätsprüfung, Kodierung und Bereitstellung ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 10.]] || HM || EN || CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS Principles based on International Conference on Harmonisation GCP Guideline [...] 10. All clinical trial information shall be recorded, ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (b)]] || HM || EN || § 312.62 Investigator recordkeeping and record retention. [...] (b) Case histories. An investigator is required to prepare and maintain adequate and accurate case histories that record all ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (3)]] || MD || EN || § 812.140 Records. […] (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator's participation in an ...
|-
| [[Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 GLOSSARY OF TERMS]] || G || EN || Certified Copy: A copy (paper or electronic) of original information that has been verified, as indicated by a dated signature, as an exact copy, having all of the same attributes and information as ...
|}

===== 4.2.2 — Common issues =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.1.8]] || G || EN || 2.1.8 Proportionate, efficient and reliable capture of data [...] Disproportionate data collection wastes time and resources. It places an unnecessary burden on trial participants and staff, ...
|-
| [[Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.4]] || G || EN || 2.4 Good clinical trials are designed to be feasible for their context […] Clinical trials should be tailored to be practicable given the available infrastructure in relevant settings. […] Clinical ...
|-
| [[Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.5]] || G || EN || 2.5 Good clinical trials manage quality effectively and efficiently The design and conduct of a high-quality trial require competent decision-making and coordinated execution. Good governance and ...
|-
| [[Reference:WHO WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Forty-fifth report -]] || G || EN || Annex 3: WHO good manufacturing practices: main principles for pharmaceutical products [...] 15. Documentation [...] 15.6 Where documents require the entry of data, these entries should be clear, ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.1.4]] || G || EN || The sponsor should ensure that all aspects of the trial are operationally feasible and should avoid unnecessary complexity, procedures and data collection. Protocols, data acquisition tools and other ...
|-
| [[Reference:EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011 4]] || G || EN || Documentation Practices 4.7 Handwritten entries should be made in clear, legible, indelible way. […] 4.9 Any alteration made to the entry on a document should be signed and dated; the alteration ...
|-
| [[Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - SD]] || G || EN || Examples of critical and major findings in the sub-categories of the three main categories "General", "Trial Management", and "Investigational Site" are listed below. [...] Source Documentation: • ...
|-
| [[Reference:AUT BASG - FAQ 11-Feb-2025 Schwarz]] || G || DE || https://basg.gv.at/gesundheitsberufe/klinische-studien/gute-klinische-praxis-und-gcp-inspektion/faq-dokumentation-gcp Ist es korrekt, dass die Verwendung eines schwarzen Kugelschreibers für Einträge ...
|-
| [[Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 2.]] || G || EN || III. Electronic Source Data [...] 2. Source Data Capture Data can be entered into the eCRF either manually or electronically as described below. a. Direct Entry of Data Into the eCRF Many data ...
|-
| [[Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015 III]] || G || EN || III. GENERAL PRINCIPLES [...] C. Source documents should be retained to enable a reconstruction and evaluation of the trial. D. When original observations are entered directly into a computerized ...
|-
| [[Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007 IV]] || G || EN || IV. RECOMMENDATIONS [...] C. Source Documentation and Retention When original observations are entered directly into a computerized system, the electronic record is the source document. Under 21 CFR ...
|-
| [[Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - CRF]] || G || EN || [...] Case Report Forms Used as Source Documents Case report forms (CRFs) may be used as source documents if data will be initially recorded on the form and the intended use is prospectively stated ...
|-
| [[Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - Note]] || G || EN || [...] Note: Using CRFs as source documents (direct and real-time entry) is different than using printed copies of electronic or paper CRFs as source documents, and then transcribing the data into the ...
|-
| [[Reference:USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3 6]] || G || EN || (A Memo for FDA Personnel on Current Good Manufacturing Practice For Human Use Pharmaceuticals) [...] 6) Are the use of ditto marks and arrows for redundant information acceptable practices under ...
|}

===== 4.2.3 — Electronic documentation =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4]] || G || EN || 4. DATA GOVERNANCE – INVESTIGATOR AND SPONSOR
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.10]] || G || EN || 2.12.10 When using computerised systems in a clinical trial, the investigator/institution should do the following: (a)For systems deployed by the investigator/institution, ensure that appropriate ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 For systems used or deployed by the investigator/institution]] || G || EN || 3.16 Data and Records 3.16.1 Data Handling [...] For systems used or deployed by the investigator/institution: [...] (vii) In situations where clinical practice computerised systems are being ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3]] || G || EN || 4.3 Computerised Systems As described in sections 2 and 3, the responsibilities of the sponsor, investigator and the activities of other parties with respect to a computerised system used in clinical ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.3]] || G || EN || 4.3.3 Security (a) The security of the trial data and records should be managed throughout the data life cycle. (b) The responsible party should ensure that security controls are implemented and ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Computerised Systems Validation]] || G || EN || Computerised Systems Validation A process of establishing and documenting that the specified requirements of a computerised system can be consistently fulfilled from design until decommissioning of ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.4]] || G || EN || 4.3.4 Validation (a) The responsible party is responsible for the validation status of the system throughout its life cycle. The approach to validation of computerised systems should be based on a ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.8]] || G || EN || 4.3.8 User Management (a) Access controls are integral to computerised systems used in clinical trials to limit system access to authorised users and to ensure attributability to an individual. The ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - validation]] || HM || EN || validation Action of proving, in accordance with the principles of Good Clinical Practice, that any procedure, process, equipment (including the software or hardware used), material, activity or ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Electronic data handling]] || HM || EN || 8. RECORD KEEPING AND HANDLING OF DATA […] In the event of electronic data handling, confidentiality of the database must be secured by safety procedures such as passwords and written assurances from ...
|-
| [[Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.2]] || G || EN || 4.2. Responsibilities Roles and responsibilities in clinical trials should be clearly defined. The responsibility for the conduct of clinical trials is assigned via legislation to two parties, which ...
|-
| [[Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.4]] || G || EN || 4.4. Source data The term source data refers to the original reported observation in a source document. Source documents could be e.g. hospital records, clinical and office charts, laboratory notes. ...
|-
| [[Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 ALCOA]] || G || EN || 4.5. ALCOA++ principles A number of attributes are considered of universal importance to data. These include that the data are: Attributable Data should be attributable to the person and/or system ...
|-
| [[Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 CCEAT]] || G || EN || 4.5. ALCOA++ principles [...] Complete To reconstruct and fully understand an event, data should be a complete representation of the observation made. This includes the associated metadata and audit ...
|-
| [[Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6]] || G || EN || 4.6. Criticality and risks For systems deployed by the investigator/institution specifically for the purposes of clinical trials, the investigator should ensure that the requirements for computerised ...
|-
| [[Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 A4.13]] || G || EN || The level of security should be proportionate to the sensitivity and confidentiality of the data (e.g. nominative data in electronic medical records are highly sensitive) and to the access rights to ...
|-
| [[Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (6)]] || G || EN || § 11.3 Definitions […] (b) The following definitions of terms also apply to this part: […] (6) Electronic record means any combination of text, graphics, data, audio, pictorial, or other information ...
|-
| [[Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.10]] || G || EN || Subpart B—Electronic Records § 11.10 Controls for closed systems. Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls ...
|-
| [[Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.30]] || G || EN || § 11.30 Controls for open systems. Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, ...
|-
| [[Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (m)]] || G || EN || (m) Written, or in writing, for purposes of this part, refers to writing on a tangible medium (e.g., paper) or in an electronic format.
|-
| [[Reference:USA 45 CFR Part 160 09-Apr-2025 -]] || G || EN || § 164.304 Definitions. […] Access means the ability or the means necessary to read, write, modify, or communicate data/information or otherwise use any system resource. […] Encryption means the use ...
|-
| [[Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 II]] || G || EN || […] Source data should be attributable, legible, contemporaneous, original, and accurate (ALCOA) and must meet the regulatory requirements for recordkeeping. […]
|-
| [[Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 4.]] || G || EN || III. Electronic Source Data […] 4. Modifications and Corrections Only a clinical investigator(s) or delegated clinical study staff should perform modifications or corrections to eCRF data. Modified ...
|}

===== 4.2.4 — Electronic signatures =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Signature]] || G || EN || Signature A unique mark, symbol or entry executed, adopted or authorised by an individual, in accordance with applicable regulatory requirements and/or practice to show expression of will and allow ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Part 1 Article 2]] || HM || EN || “electronic signature” means data in electronic form which are attached to or logically associated with other electronic data and which serve as a method of authentication;
|-
| [[Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 Article 3 Paragraph 10]] || G || EN || ‘electronic signature’ means data in electronic form which is attached to or logically associated with other data in electronic form and which is used by the signatory to sign;
|-
| [[Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 -]] || G || EN || Best summarized in this FAQ from the European Commission: https://ec.europa.eu/digital-building-blocks/sites/display/digital/eSignature+FAQ Simple' electronic signatures An electronic signature is ...
|-
| [[Reference:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 14]] || G || EN || Annex 11: Computerised Systems 14. Electronic Signature Electronic records may be signed electronically. Electronic signatures are expected to: a. have the same impact as hand-written signatures ...
|-
| [[Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.8]] || G || EN || 4.8. Electronic signatures Whenever ICH E6 requires a document to be signed and an electronic signature is used for that purpose, the electronic signature functionality should meet the expectations ...
|-
| [[Reference:GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019 -]] || G || EN || Summarized in "Electronic Execution of Documents - Industry Working Group Interim Report" (01-Feb-2022) ...
|-
| [[Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (5) ; (b) (7) ; (b) (8)]] || G || EN || § 11.3 Definitions […] (b) The following definitions of terms also apply to this part: […] (5) Digital signature means an electronic signature based upon cryptographic methods of originator ...
|-
| [[Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.50]] || G || EN || § 11.50 Signature manifestations (a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: (1) The printed name of the signer; ...
|-
| [[Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.70]] || G || EN || § 11.70 Signature/record linking. Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures ...
|-
| [[Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.100]] || G || EN || Subpart C—Electronic Signatures § 11.100 General requirements (a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else. (b) Before an ...
|-
| [[Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.200]] || G || EN || § 11.200 Electronic signature components and controls (a) Electronic signatures that are not based upon biometrics shall: (1) Employ at least two distinct identification components such as an ...
|-
| [[Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.300]] || G || EN || § 11.300 Controls for identification codes/passwords. Persons who use electronic signatures based upon use of identification codes in combination with passwords shall employ controls to ensure their ...
|}

===== 4.2.5 — CRF / eCRF =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Case Report Form (CRF)]] || G || EN || Case Report Form (CRF) A tool designed to record protocol-required information to be reported by the investigator to the sponsor on each trial participant (see Data Acquisition Tool).
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Data Acquisition Tool (DAT)]] || G || EN || Data Acquisition Tool (DAT) A paper or electronic tool designed to collect data and associated metadata from a data originator in a clinical trial according to the protocol and to report the data to ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.1]] || G || EN || 4.2 Data Life Cycle Elements Procedures should be in place to cover the full data life cycle. 4.2.1 Data Capture (a) When data captured on paper or in an electronic health record are manually ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.3 - 4.2.4]] || G || EN || 4.2.3 Review of Data and Metadata Procedures for review of trial-specific data, audit trails and other relevant metadata should be in place. It should be a planned activity, and the extent and nature ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - case -report form (CRF)]] || HM || EN || case -report form (CRF) A document that is used to record data on each trial subject during the course of the trial, as defined by the protocol. The data should be collected by procedures which ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.6]] || MD || EN || Case report forms (CRFs) […]
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 56]] || HM || EN || Recording, processing, handling and storage of information 1. All clinical trial information shall be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 57]] || HM || EN || Clinical trial master file The sponsor and the investigator shall keep a clinical trial master file. The clinical trial master file shall at all times contain the essential documents relating to that ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 3 – 4-001]] || MD || EN || Conduct of a clinical investigation [...] 3. All clinical investigation information shall be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Paragraph 3]] || MD || EN || OTHER OBLIGATIONS OF THE SPONSOR 3. The documentation mentioned in this Annex shall be kept for a period of at least 10 years after the clinical investigation with the device in question has ended, ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 3 – 4-001]] || IVD || EN || Conduct of a performance study 3. All performance study information shall be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that it can be ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 3-001]] || IVD || EN || OTHER OBLIGATIONS OF THE SPONSOR 3. The documentation mentioned in this Annex shall be kept for a period of time of at least 10 years after the clinical performance study with the device in question ...
|-
| [[Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.8]] || NIS || DE || Leitlinie 6 (Qualitätssicherung) [...] Empfehlung 6.8 Die Datenerfassung erfolgt nach Möglichkeit elektronisch. Die Erhebungsmethode soll der Population und der Situation angepasst sein und begründet ...
|-
| [[Reference:USA 21 CFR Part 314 09-Apr-2025 § 314.50]] || HM || EN || § 314.50 Content and format of an NDA. (f) Case report forms and tabulations. The archival copy of the NDA is required to contain the following case report tabulations and case report forms: (1) Case ...
|}

===== 4.2.6 — Conclusion - SD and CRF =====

==== Monitoring ====

===== 4.3.1 — Purpose =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4 3.11.4.3 - 3.11.4.6]] || G || EN || 3.11 Quality Assurance and Quality Control [...] 3.11.4 Monitoring The aim of monitoring is to ensure the participants’ rights, safety and well-being and the reliability of trial results as the trial ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - monitor]] || HM || EN || monitor A person appointed by, and responsible to, the sponsor or Contract Research Organization (CRO) for the monitoring and reporting of progress of the trial and for verification of data.
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - verification (validation) of data]] || HM || EN || verification (validation) of data The procedures carried out to ensure that the data contained in the final report match original observations. These procedures may apply to raw data, data in ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-001]] || HM || EN || 4.12 Monitoring, auditing and inspection The investigator must be prepared to receive and be available for periodic visits by the monitor(s) and accept the implications of such visits (see also ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 6]] || HM || EN || 6. RESPONSIBILITIES OF THE MONITOR […] 6.2 Assessment of the trial site […] 6.3 Staff education and compliance The monitor should ensure that all staff assisting the investigator in the trial have ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.4]] || MD || EN || 9.2.4 Monitoring 9.2.4.1 General Monitoring shall [...] 9.2.4.2 Qualifications of the monitor Monitors shall be [...] 9.2.4.3 Assessment of the investigation site The monitor shall assess [...] ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 48]] || HM || EN || Monitoring In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the clinical trial is in ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Pragraph 2]] || MD || EN || Conduct of a clinical investigation 2. In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Section 4]] || MD || EN || OTHER OBLIGATIONS OF THE SPONSOR 4. The Sponsor shall appoint a monitor that is independent from the investigational site to ensure that the investigation is conducted in accordance with the CIP, the ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 2]] || IVD || EN || Conduct of a performance study 2. In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 4]] || IVD || EN || OTHER OBLIGATIONS OF THE SPONSOR 4. The sponsor shall appoint a monitor that is independent of the investigation site to ensure that the clinical performance study is conducted in accordance with the ...
|-
| [[Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Monitoring]] || G || EN || Examples of critical and major findings in the sub-categories of the three main categories "General", "Trial Management", and "Investigational Site" are listed below. [...] Monitoring: • The process ...
|-
| [[Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.3]] || NIS || DE || 2.7.3. Qualitätssicherung Die für epidemiologische Studien üblichen Qualitätsanforderungen gelten auch für Anwendungsbeobachtungen. Ziel der Qualitätssicherung ist es, mögliche Verzerrungen durch ...
|-
| [[Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.5 - 6.7]] || NIS || DE || Leitlinie 6 (Qualitätssicherung) [...] Empfehlung 6.5 Insbesondere bei großen, zeitlich lang dauernden und multizentrischen Untersuchungen ist zu überprüfen, ob eine Qualitätssicherung der Verfahren ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (d)]] || HM || EN || § 312.53 Selecting investigators and monitors. […] (d) Selecting monitors. A sponsor shall select a monitor qualified by training and experience to monitor the progress of the investigation.
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (j)]] || MD || EN || (j) Monitor, when used as a noun, means an individual designated by a sponsor or contract research organization to oversee the progress of an investigation. The monitor may be an employee of a ...
|}

===== 4.3.2 — Monitor's visits =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 6.2]] || HM || EN || 6.2 Assessment of the trial site The monitor should assess the trial site prior to the clinical trial to ensure that the facilities (including laboratories, equipment and staff) are adequate, and ...
|-
| [[Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI D.]] || G || EN || VI. ADDITIONAL STRATEGIES TO ENSURE STUDY QUALITY […] D. Clinical Investigator and Site Selection and Initiation In addition to regulatory requirements for CI selection, sponsors should consider ...
|}

===== 4.3.3 — Types of Monitoring =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4 3.11.4.1 - 3.11.4.2]] || G || EN || 3.11.4 Monitoring [...] Monitoring activities may include site monitoring (performed on-site or remotely) and centralised monitoring, depending on the monitoring strategy and the design of the ...
|-
| [[Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.4]] || HM || EN || 4.4. Trial management Monitoring Monitoring activities should focus on preventing or mitigating important and likely sources of error in the conduct, collection, and reporting of critical data and ...
|-
| [[Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Q1.2]] || HM || EN || Q1.2: How to apply risk-proportionate approaches to CCTs? Proportionate risk-based approaches should be applied for complex clinical trials, with risks to both trial participants and the reliability ...
|-
| [[Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III - IV.]] || G || EN || III. OVERVIEW OF MONITORING METHODS A. On-Site and Centralized Monitoring 1. On-Site Monitoring 2. Centralized Monitoring B. Examples of Alternative Monitoring Techniques 1. Communication with Study ...
|-
| [[Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III B. 3.]] || G || EN || III. OVERVIEW OF MONITORING METHODS B. Examples of Alternative Monitoring Techniques […] 3. Source Data Verification and Corroboration The sponsor should consider the quantity and types of source ...
|-
| [[Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A.]] || G || EN || IV. RISK-BASED MONITORING […] A. Identify Critical Data and Processes to be Monitored […] Other types of data (e.g., covariates such as concomitant treatments or demographic characteristics, routine ...
|}

===== 4.3.4 — National requirements for remote Source Data Verification =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 11 d)]] || G || EN || d) Remote source data verification […] Remote SDV may be considered for trials: - involving COVID-19 treatment or prevention; - investigating serious or life-threatening conditions; - where the ...
|-
| [[Reference:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 Annex 1]] || G || EN || Annex 1: Protection of trial participants’ rights during remote source data verification […] - A documented risk assessment should be performed […] - Site staff and monitors should be trained on the ...
|-
| [[Reference:DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021 -]] || G || DE || Ergänzende Empfehlungen des BfArM und des PEI zur Europäischen Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic […] Unabhängig von der gewählten Methode für ...
|-
| [[Reference:AUT FAQ - COVID-19 Studien 15-Mar-2021 -]] || G || DE || Nationale Regelung zum Quelldatenvergleich aus der Ferne (remote SDV) Auch nach der Aktualisierung der Empfehlungen auf europäischer Ebene gehört Österreich weiter zu jenen Staaten, die einem ...
|-
| [[Reference:FRA Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) 16-May-2024 -]] || G || FR || [...] La surveillance à distance d’une étude peut donc être mise en place, après avoir été autorisée par la CNIL. Dans cette hypothèse, il est nécessaire de documenter spécifiquement la mise en place ...
|-
| [[Reference:GBR Making changes to a research study to manage the impact of COVID-19 12-Oct-2021 -]] || G || EN || […] Remote monitoring and source data verification must not result in confidential patient information being sent to the sponsor or stored by the sponsor if this has not alreadybeen addressed in the ...
|-
| [[Reference:GBR Guidance Managing clinical trials during Coronavirus (COVID-19) 16-Nov-.2021 -]] || G || EN || 1. Where read-only user role is not a feature of the EHR system, there is a risk that Monitors (or Auditors) could enter/edit/delete data or information in the EHR system. It should be noted that ...
|-
| [[Reference:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 -]] || G || EN || Remote direct access to Electronic Health Records (EHR) by Sponsor Monitors (or Auditors) in clinical trials [...] Remote direct access to the health records of clinical trial participants may be ...
|-
| [[Reference:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 System Security]] || G || EN || System Security [...] There should be the implementation of robust security procedures by the sponsor and investigator site/institution, such as; password criteria and renewal rules, firewalls, virus ...
|-
| [[Reference:USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020 Q15]] || G || EN || Q15. I am a study monitor and am unable to conduct on-site monitoring visits due to the COVID-19 public health emergency. May I remotely perform the site monitoring visit? What recommendations does ...
|}

==== Changes and amendments ====

==== Audits and Inspections ====

===== 4.5.1 — Audits =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Audit]] || G || EN || Audit A systematic and independent examination of trial-related activities and records performed by the sponsor, service provider (including contract research organisation (CRO)) or institution to ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.2]] || G || EN || 3.11 Quality Assurance and Quality Control [...] 3.11.2 Audit When performed, audits should be conducted in a manner that is proportionate to the risks associated with the conduct of the trial (see ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - audit of a trial]] || HM || EN || audit of a trial A systematic examination, carried out independently of those directly involved in the trial, to determine whether the conduct of a trial complies with the agreed protocol and whether ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-002]] || HM || EN || 4.12 Monitoring, auditing and inspection The investigator must be prepared to receive and be available for periodic visits by the monitor(s) and accept the implications of such visits (see also ...
|-
| [[Reference:IMDRF IMDRF – Guidelines - -]] || MD || EN || IMDRF: International Medical Device Regulators Forum ; Global Harmonization Task Force (GHTF) GHTF Study Group 4 – Auditing ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex J]] || MD || EN || Clinical investigation audits
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.11]] || MD || EN || 7.11 Auditing [...] An audit can be used [...]
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 17]] || HM || EN || PROTOCOL [...] 17.The protocol shall at least include: [...] (ah) a statement from the sponsor (either in the protocol or in a separate document) confirming that the investigators and institutions ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2]] || HM || EN || Definitions [...] (30) ‘Good clinical practice’ means a set of detailed ethical and scientific quality requirements for designing, conducting, performing, monitoring, auditing, recording, analysing ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 109 Paragraph 1-001]] || MD || EN || Confidentiality 1. Unless otherwise provided for in this Regulation and without prejudice to existing national provisions and practices in the Member States on confidentiality, all parties involved ...
|}

===== 4.5.2 — Inspections =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Inspection]] || G || EN || Inspection The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records and any other resources that are deemed by the authority(ies) to be related to the ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - inspection]] || HM || EN || inspection An officially-conducted examination (i.e. review of the conduct of the trial, including quality assurance, personnel involved, any delegation of authority and audit) by relevant ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-003]] || HM || EN || 4.12 Monitoring, auditing and inspection The investigator must be prepared to receive and be available for periodic visits by the monitor(s) and accept the implications of such visits (see also ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11.2]] || HM || EN || 11.2 On-site inspections As permitted by national regulations, the drug regulatory authority may carry out on-site inspections of the clinical trial site. Such inspections may be carried out ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 78]] || HM || EN || Member State inspections 1. Member States shall appoint inspectors to perform inspections in order to supervise compliance with this Regulation. They shall ensure that those inspectors are adequately ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Pragraph 5]] || MD || EN || Conduct of a clinical investigation 5. Member States shall inspect, at an appropriate level, investigation site(s) to check that clinical investigations are conducted in accordance with the ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 109 Paragraph 1-002]] || MD || EN || Confidentiality 1. Unless otherwise provided for in this Regulation and without prejudice to existing national provisions and practices in the Member States on confidentiality, all parties involved ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 5]] || IVD || EN || Conduct of a performance study 5. Member States shall inspect, at an appropriate level, performance study site(s) to check that performance studies are conducted in accordance with the requirements ...
|-
| [[Reference:EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012 5]] || G || EN || 5. Results 5.1. Overview of GCP inspections requested by the CHMP and carried out between 2000-2012 Between 2000-2012, a total of 398 site inspections were carried out. The distribution of the number ...
|-
| [[Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 a)]] || G || EN || 3.1.2. Categorisation of findings a) General overview A total of 470 deficiencies, comprising 17 critical (3.6%), 260 major (55.3%) and 193 minor (41.1%) findings were recorded for the 36 CHMP ...
|-
| [[Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 4.3]] || G || EN || 4.3. Inspection cooperation • Cooperation between the EU/EEA MSs: Nearly all the inspections conducted in 2022 were joint inspections involving inspectors from at least two MSs. Only two inspections ...
|-
| [[Reference:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-002]] || G || EN || 2.5. Personnel Points to consider: […] • Relationship of the Investigator with the Sponsor company. […]
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42c]] || HM || DE || § 42c Inspektionen Die folgenden Inspektionen nach Artikel 78 der Verordnung (EU) Nr. 536/2014 werden durch die zuständige Bundesoberbehörde durchgeführt: 1. Inspektionen zur Überprüfung der ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 68]] || MD || DE || § 68 Überwachung von klinischen Prüfungen, Leistungsstudien und sonstigen klinischen Prüfungen durch die zuständige Behörde (1) Die zuständige Behörde überprüft in angemessenem Umfang, ob Betriebe ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 77]] || MD || DE || § 77 Durchführung der Überwachung (1) Der Überwachung durch die zuständigen Behörden unterliegen 1. Betriebe und Einrichtungen, in denen Produkte und Produkte nach § 2 Absatz 2 hergestellt, klinisch ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 79]] || MD || DE || § 79 Behördliche Befugnisse im Rahmen der Durchführung der Vigilanz und der Überwachung (1) Die mit der Risikobewertung und der Überwachung beauftragten Personen sind befugt, 1. Grundstücke, ...
|-
| [[Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (l)]] || HM || EN || (l)‘inspection’: the act by a competent authority of conducting an official review of documents, facilities, records, quality assurance arrangements, and any other resources that are deemed by the ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.58]] || HM || EN || § 312.58 Inspection of sponsor's records and reports. (a) FDA inspection. A sponsor shall upon request from any properly authorized officer or employee of the Food and Drug Administration, at ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.68]] || HM || EN || § 312.68 Inspection of investigator's records and reports. An investigator shall upon request from any properly authorized officer or employee of FDA, at reasonable times, permit such officer or ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.145]] || MD || EN || § 812.145 Inspections (a) Entry and inspection. A sponsor or an investigator who has authority to grant access shall permit authorized FDA employees, at reasonable times and in a reasonable manner, ...
|-
| [[Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.1-002]] || G || EN || § 54.1 Purpose. (a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in marketing applications, required by law, for new human drugs and biological products and marketing ...
|}

=== Module 5: Adverse events and Safety ===

==== Adverse Events - Definitions ====

===== 5.1.1 — Adverse Events =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Event (AE)]] || G || EN || Adverse Event (AE): Any unfavourable medical occurrence in a trial participant administered the investigational product. The adverse event does not necessarily have a causal relationship with the ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Serious Adverse Event (SAE)]] || G || EN || Serious Adverse Event (SAE): Any unfavourable medical occurrence that is considered serious at any dose if it: • Results in death, • Is life-threatening, • Requires inpatient hospitalisation or ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.1]] || G || EN || 3.13.1 Sponsor Review of Safety Information The sponsor should aggregate, as appropriate, and review in a timely manner relevant safety information. This includes the review of any reported ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a)]] || G || EN || 2.7.2 Safety Reporting (a) [...] Unfavourable medical events occurring in participants before investigational product administration (e.g., during screening) should be considered and reported to the ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse event]] || HM || EN || adverse event Any untoward medical occurrence in a clinical trial subject administered a pharmaceutical product; it does not necessarily have a causal relationship with the treatment.
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - serious adverse event]] || HM || EN || serious adverse event An event that is associated with death, admission to hospital, prolongation of a hospital stay, persistent or significant disability or incapacity, or is otherwise ...
|-
| [[Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Oversight]] || G || EN || Research Ethics Committees 23. […] The committee must have the right to monitor, recommend changes to, withdraw approval for, and suspend ongoing research. Where monitoring is required, the ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.2]] || MD || EN || adverse event AE […]
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.45]] || MD || EN || 3.45 serious adverse event SAE […]
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 32-34]] || HM || EN || (32) ‘Adverse event’ means any untoward medical occurrence in a subject to whom a medicinal product is administered and which does not necessarily have a causal relationship with this treatment; (33) ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 19]] || HM || EN || 19. With regard to the notification of adverse events, the protocol shall identify the categories of: (a) adverse events or laboratory anomalies that are critical to safety evaluations and must be ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 57 – 59]] || MD || EN || (57) ‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 60 – 62]] || IVD || EN || (60) ‘adverse event’ means any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory ...
|-
| [[Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.1]] || G || EN || Communication from the Commission — Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Adverse event]] || HM || EN || Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Life-threatening Adverse event]] || HM || EN || Life-threatening adverse event or life-threatening suspected adverse reaction. An adverse event or suspected adverse reaction is considered “life-threatening” if, in the view of either the ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - SAE]] || HM || EN || Serious adverse event or serious suspected adverse reaction. An adverse event or suspected adverse reaction is considered “serious” if, in the view of either the investigator or sponsor, it results ...
|-
| [[Reference:USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017) -]] || G || EN || Introduction The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 adverse event adverse reaction]] || HM || EN || “adverse event” means any untoward medical occurrence in a subject to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 serious adverse event]] || HM || EN || “serious adverse event”, “serious adverse reaction” or “unexpected serious adverse reaction” means any adverse event, adverse reaction or unexpected adverse reaction, respectively, that— (a)results ...
|-
| [[Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (m)]] || HM || EN || (m)‘adverse event’: any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this ...
|-
| [[Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (o)]] || HM || EN || (o)‘serious adverse event or serious adverse reaction’: any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires hospitalisation or prolongation of ...
|-
| [[Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.1.]] || G || EN || 2.1.1. Adverse Event (AE or Adverse Experience): Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY ...
|-
| [[Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.28]] || G || EN || 2.1.28. Serious Adverse Event (SAE): Any adverse drug event (experience) occurring at any dose that results in ANY of the following outcomes: 1. Death. 2. A life-threatening adverse drug experience. ...
|-
| [[Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.14.]] || G || EN || 2.1.14. Hospitalization (or prolongation of hospitalization): NCI defines hospitalization for expedited AE reporting purposes as an inpatient hospital stay equal to or greater than 24 hours. ...
|-
| [[Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.21.]] || G || EN || 2.1.21. Life-Threatening Adverse Event: Any SAE that places the subject, in the view of either the investigator or the sponsor (NCI), at immediate risk of death from the AE as it occurred. It does ...
|-
| [[Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.1]] || G || EN || 5.1 Pre-existing Conditions (formerly referred to as Baseline AEs) A pre-existing medical condition identified on baseline assessment is not considered an AE and should not be reported as a routine ...
|-
| [[Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.2]] || G || EN || 5.2 Pre-Treatment AEs A pre-treatment adverse event is an adverse event that occurs after a participant has signed an informed consent, but before intervention has begun. Refer to the protocol ...
|}

===== 5.1.2 — Special categories – defined by protocol =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E19 Guideline 2022 6]] || G || EN || [...] Adverse Event of Special Interest: An event (serious or non-serious) of scientific and medical concern specific to the sponsor’s product or programme, for which ongoing monitoring and rapid ...
|}

===== 5.1.3 — Special categories – causal relationship with IP =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Drug Reaction (ADR)]] || G || EN || Adverse Drug Reaction (ADR): • in the pre-approval clinical experience with a new investigational product or its new usages (particularly as the therapeutic dose(s) may not be established): ...
|-
| [[Reference:ICH ICH E2A Guideline 1994 II B. Serious Adverse Event or Adverse Drug Reaction]] || G || EN || Serious Adverse Event or Adverse Drug Reaction During clinical investigations, adverse events may occur which, if suspected to be medicinal product-related (adverse drug reactions), might be ...
|-
| [[Reference:ICH ICH E2A Guideline 1994 II B. Serious/Severe]] || G || EN || […] To ensure no confusion or misunderstanding of the difference between the terms "serious" and "severe," which are not synonymous, the following note of clarification is provided: The term "severe" ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse reaction]] || HM || EN || adverse reaction A response to a pharmaceutical product that is noxious and unintended and which occurs at doses normally used or tested in man for prophylaxis, diagnosis, or therapy of disease, or ...
|-
| [[Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.2]] || G || EN || Communication from the Commission — Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human ...
|-
| [[Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 8]] || MD || EN || 8. CAUSALITY ASSESSMENT The relationship between the use of the medical device (including the medical - surgical procedure) and the occurrence of each adverse event shall be assessed and categorized. ...
|-
| [[Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (n)]] || HM || EN || (n)‘adverse reaction’: all untoward and unintended responses to an investigational medicinal product related to any dose administered;
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Suspected adverse reaction]] || HM || EN || Suspected adverse reaction means any adverse event for which there is a reasonable possibility that the drug caused the adverse event. For the purposes of IND safety reporting, “reasonable ...
|-
| [[Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.2]] || G || EN || 2.1.2. Attribution: An assessment of the relationship between the AE and the medical intervention. After naming and grading the event, the clinical investigator must assign an attribution to the AE ...
|}

===== 5.1.4 — Special categories – Unexpectedness =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E2A Guideline 1994 II A. 3.]] || G || EN || Unexpected Adverse Drug Reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved ...
|-
| [[Reference:ICH ICH E2A Guideline 1994 III A. 1.]] || G || EN || [...] Causality assessment is required for clinical investigation cases. All cases judged by either the reporting health care professional or the sponsor as having a reasonable suspected causal ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Suspected Unexpected Serious Adverse Reaction (SUSAR)]] || G || EN || Suspected Unexpected Serious Adverse Reaction (SUSAR): an adverse reaction that meets three criteria: suspected, unexpected and serious. • Suspected: There is a reasonable possibility that the drug ...
|-
| [[Reference:ICH ICH E2A Guideline 1994 III A. 2.]] || G || EN || 2. Other Observations There are situations in addition to single case reports of "serious" adverse events or reactions that may necessitate rapid communication to regulatory authorities; appropriate ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.51]] || MD || EN || unanticipated serious adverse device effect USADE […]
|-
| [[Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.3]] || G || EN || Communication from the Commission — Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 unexpected adverse reaction]] || HM || EN || “unexpected adverse reaction” means an adverse reaction the nature and severity of which is not consistent with the information about the medicinal product in question set out— (a)in the case of a ...
|-
| [[Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (p)]] || HM || EN || (p)‘unexpected adverse reaction’: an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. investigator's brochure for an unauthorised ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Unexpected adverse event]] || HM || EN || Unexpected adverse event or unexpected suspected adverse reaction. An adverse event or suspected adverse reaction is considered “unexpected” if it is not listed in the investigator brochure or is not ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (s)]] || MD || EN || (s) Unanticipated adverse device effect means any serious adverse effect on health or safety or any lifethreatening problem or death caused by, or associated with, a device, if that effect, problem, ...
|-
| [[Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 III A. ; IV.]] || G || EN || [...] III. REPORTING AEs TO IRBs IN CLINICAL TRIALS OF DRUG AND BIOLOGICAL PRODUCTS CONDUCTED UNDER IND REGULATIONS A. How to Determine If an AE is an Unanticipated Problem that Needs to Be Reported ...
|-
| [[Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.32 - 2.1.34]] || G || EN || 2.1.32. Suspected Unexpected Serious Adverse Reaction (SUSAR): An adverse event that occurs in a clinical trial participant, which is assessed by the sponsor as being unexpected, unexpected, serious ...
|}

===== 5.1.5 — Summary and clarification =====

===== 5.1.6 — Medical Devices – specific terms =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.1]] || MD || EN || adverse device effect ADE […]
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.19]] || MD || EN || 3.19 device deficiency […]
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.33]] || MD || EN || 3.33 malfunction […]
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.52]] || MD || EN || use error […]
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex F]] || MD || EN || Adverse event categorization
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 64 – 66]] || MD || EN || (64) ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 67–69]] || IVD || EN || (67) ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any ...
|-
| [[Reference:DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021 § 2]] || MD || DE || § 2 Ergänzende Begriffsbestimmungen Ergänzend zu Artikel 2 der Verordnung (EU) 2017/745 und Artikel 2 der Verordnung (EU) 2017/746 bezeichnet im Sinne dieser Rechtsverordnung der Ausdruck ...
|}

==== Adverse Events – Investigator’s duties ====

===== 5.2.1 — General requirements =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) - (d)]] || G || EN || 2.7.2 Safety Reporting (a) Adverse events and/or abnormal test results required for safety evaluations (as outlined in the protocol) should be reported to the sponsor according to the reporting ...
|-
| [[Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.4 - 2.5]] || G || EN || 2.4 Investigator Oversight […] 2.5 Safety Assessment and Reporting For the safety monitoring of individual trial participants (see Annex 1, section 2.7), the investigator should review and assess ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.10]] || HM || EN || 4.10 Serious adverse events/reactions The investigator must take appropriate measures to ensure the safety of clinical trial subjects (see also Section 7). The investigator is also responsible for ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Investigator]] || HM || EN || 7.1 Handling of and recording adverse events In accordance with Sections 4.1 and 4.3 of these guidelines, the investigator must ensure the safety of the trial subjects. This includes providing the ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - Investigator]] || HM || EN || 7.2 Reporting […] The investigator The investigator has to report serious adverse events to the sponsor immediately and to the drug regulatory authority and the ethics committee as specified in the ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.8]] || MD || EN || 10.8 Safety reporting The principal investigator shall […]
|}

===== 5.2.2 — Human Medicines =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-001]] || HM || EN || Reporting of adverse events and serious adverse events by the investigator to the sponsor 1. The investigator shall record and document adverse events or laboratory abnormalities identified in the ...
|}

===== 5.2.3 — Medical Devices =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001]] || MD || EN || 8 Reporting timelines [...] 8.2 Report by the investigator to the sponsor The sponsor shall implement and maintain a system to ensure that the reporting of the reportable events as defined under ...
|}

===== 5.2.4 — National requirements =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-002]] || HM || DE || § 40d Besondere Pflichten des Prüfers, des Sponsors und der zuständigen Bundesoberbehörde Bei klinischen Prüfungen mit Arzneimitteln, die aus einem gentechnisch veränderten Organismus oder einer ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 32]] || HM || EN || Notification of adverse events 32.—(1) An investigator shall report any serious adverse event which occurs in a subject at a trial site at which he is responsible for the conduct of a clinical trial ...
|-
| [[Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 16]] || HM || EN || Notification of adverse events 1. The investigator shall report all serious adverse events immediately to the sponsor except for those that the protocol or investigator's brochure identifies as not ...
|-
| [[Reference:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 2.-001]] || MD || EN || 2. Clinical Investigation Plan [….] Description of procedures and details of data to record and report serious adverse events and adverse device related incidents (in line with requirements in MEDDEV ...
|-
| [[Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-002]] || MD || EN || 8 Reporting timelines [...] 8.2 Report by the investigator to the sponsor The sponsor shall implement and maintain a system to ensure that the reporting of the reportable events as defined under ...
|-
| [[Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.2]] || MD || EN || 7. REPORTING TIMELINES [...] 7.2 Report by the investigator to the sponsor The sponsor shall implement and maintain a system to ensure that the reporting of the reportable events as defined under ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64 (b)]] || HM || EN || § 312.64 Investigator reports. [...] (b) Safety reports. An investigator must immediately report to the sponsor any serious adverse event, whether or not considered drug related, including those ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (3) (ii)]] || MD || EN || § 812.140 Records. (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator's participation in an ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (1)]] || MD || EN || § 812.150 Reports. (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: (1) Unanticipated adverse device effects. An investigator ...
|-
| [[Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; IV.]] || G || EN || [...] For clinical investigations of drug and biological products conducted under an investigational new drug (IND) application, information about adverse events5 must be communicated among ...
|-
| [[Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.3]] || G || EN || 1.3 Investigator Responsibility • Clinical investigators and ultimately the protocol Principal Investigator (PI) have the primary responsibility for AE identification, documentation, grading, and ...
|-
| [[Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 4.3]] || G || EN || 4.3 Expedited AE (i.e., SAE) Reporting Timelines Appendices 1 and 2 detail the expedited reporting requirements for AEs that occur on trials utilizing an agent under an NCI IND/IDE or CIP Studies ...
|-
| [[Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 Appendix 1]] || G || EN || Appendix 1: Expedited Reporting Requirements for NCI IND/IDE Agents Phase 0 Studies: Expedited Reporting Requirements for Adverse Events that Occur on Studies under an IND/IDE within 30 Days of the ...
|-
| [[Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.1]] || G || EN || 5.3.1 Persistent AE A persistent AE (e.g., chronic) is one that extends continuously, without resolution between treatment cycles/courses. Instructions for ROUTINE reporting: • For legacy studies ...
|-
| [[Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.2]] || G || EN || 5.3.2 Recurrent AEs A recurrent AE is one that occurs and resolves during a cycle/course of therapy and then reoccurs in a later cycle/course. Instructions for ROUTINE reporting: An AE that resolves ...
|}

==== Adverse Events – Sponsor’s duties ====

===== 5.3.1 — General requirements =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E2A Guideline 1994 III B. - III C.]] || G || EN || CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING III. STANDARDS FOR EXPEDITED REPORTING B. Reporting Time Frames 1. Fatal or Life-Threatening Unexpected ADRs Certain ...
|-
| [[Reference:ICH ICH E2A Guideline 1994 III E]] || G || EN || Miscellaneous Issues 1. Reactions Associated with Active Comparator or Placebo Treatment It is the sponsor's responsibility to decide whether active comparator drug reactions should be reported to ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.2 (a) - (b) ; (d) - (f)]] || G || EN || 3.13.2 Safety Reporting (a) The sponsor should submit to the regulatory authority(ies) safety updates and periodic reports, including changes to the Investigator’s Brochure, as required by applicable ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.13]] || HM || EN || 5.13 Handling of adverse events The sponsor should provide special forms for reporting any adverse event that occur during the clinical trial. The sponsor must investigate promptly, together with the ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Sponsor]] || HM || EN || 7.1 Handling of and recording adverse events […] The occurrence of adverse events must be monitored carefully and recorded in detail during the course of the clinical trial. The trial protocol should ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - Sponsor]] || HM || EN || 7.2 Reporting […] The sponsor During the trial, the sponsor is responsible for reporting and trial-related adverse events or reactions associated with the use of the investigational product to the ...
|}

===== 5.3.2 — Committees =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Independent Data Monitoring Committee (IDMC)]] || G || EN || Independent Data Monitoring Committee (IDMC) An independent data monitoring committee (e.g., data safety monitoring board) that may be established by the sponsor to assess at intervals the progress ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9]] || G || EN || 3.9 Sponsor Oversight [...] 3.9.7 The sponsor may consider establishing an IDMC to assess the progress of a clinical trial, including the safety data and the efficacy endpoints, at intervals and to ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 8]] || G || EN || Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) [...] B.8 Assessment of Efficacy B.8.1 Specification of the efficacy parameters, where applicable. B.8.2 Methods and timing for ...
|-
| [[Reference:ICH ICH E9 Guideline 1998 Glossary - IDMC]] || HM || EN || Independent Data Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee) An independent data-monitoring committee that may be established by ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Committee]] || HM || EN || 7.1 Handling of and recording adverse events […] Consideration should be given to establishing a special committee to monitor adverse events (see also Section 13).
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 13]] || HM || EN || 13. CONSIDERATIONS FOR MULTICENTRE TRIALS […] For example, a committee or an individual could be responsible for overseeing the initiation overall performance of the trial. Similarly, a second ...
|-
| [[Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 78]] || G || EN || What is an Independent Data and Safety Monitoring Board (DSMB, also known as an independent Data Monitoring Committee [DMC])? An independent data and safety monitoring board (DSMB) is a group of ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.5]] || MD || EN || 9.2.5 Safety evaluation and reporting The sponsor is responsible for […]
|}

===== 5.3.3 — DSUR =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E2F Guideline 2010 1]] || G || EN || The Development Safety Update Report (DSUR) proposed in this guideline is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are under ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.2 (c)]] || G || EN || 3.13.2 Safety Reporting [...] (c) Safety reporting to regulatory authorities should be undertaken by assessing the expectedness of the reaction in relation to the applicable product information ...
|}

===== 5.3.4 — Human Medicines =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-002]] || HM || EN || Reporting of adverse events and serious adverse events by the investigator to the sponsor 1. The investigator shall record and document adverse events or laboratory abnormalities identified in the ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 42]] || HM || EN || Reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency 1. The sponsor of a clinical trial performed in at least one Member State shall report electronically and ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 43]] || HM || EN || Annual reporting by the sponsor to the Agency 1. Regarding investigational medicinal products other than placebo, the sponsor shall submit annually through the database referred to in Article 40(1) ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 53]] || HM || EN || Other reporting obligations relevant for subject safety 1. The sponsor shall notify the Member States concerned through the EU portal of all unexpected events which affect the benefit-risk balance of ...
|}

===== 5.3.5 — Medical Devices =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 1, 3 & 4]] || MD || EN || Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination 1. If the sponsor has temporarily halted a clinical investigation or has ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 1-2]] || MD || EN || Recording and reporting of adverse events that occur during clinical investigations 1. The sponsor shall fully record all of the following: (a) any adverse event of a type identified in the clinical ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 3]] || MD || EN || 3. The sponsor shall also report to the Member States in which the clinical investigation is being conducted any event referred to in paragraph 2 of this Article that occurred in third countries in ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 4]] || MD || EN || 4. In the case of a clinical investigation for which the sponsor has used the single application referred to in Article 78, the sponsor shall report any event as referred to in paragraph 2 of this ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 5 – 6]] || MD || EN || 5. In the case of PMCF investigations referred to in Article 74(1), the provisions on vigilance laid down in Articles 87 to 90 and in the acts adopted pursuant to Article 91 shall apply instead of ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 87 Paragraph 1 – 2]] || MD || EN || Reporting of serious incidents and field safety corrective actions 1. Manufacturers of devices made available on the Union market, other than investigational devices, shall report, to the relevant ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 87 Paragraph 3 – 5]] || MD || EN || 3. Manufacturers shall report any serious incident as referred to in point (a) of paragraph 1 immediately after they have established the causal relationship between that incident and their device or ...
|-
| [[Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-001]] || MD || EN || 8 Reporting timelines 8.1 Report by sponsor to NCAs. The sponsor must report to all NCAs where the clinical investigation is authorised to start: • For all reportable events as described in section 5 ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 1]] || IVD || EN || Recording and reporting of adverse events that occur during performance studies 1. The sponsor shall fully record all of the following: (a) any adverse event of a type identified in the performance ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 73 Paragraph 1, 3, 4]] || IVD || EN || Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination 1. If the sponsor has temporarily halted a performance study or has terminated ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 2 – 3]] || IVD || EN || Recording and reporting of adverse events that occur during performance studies 2. The sponsor shall report without delay to all Member States in which a performance study is being conducted all of ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 4]] || IVD || EN || 4. In the case of a performance study for which the sponsor has used the single application referred to in Article 74, the sponsor shall report any event as referred to in paragraph 2 of this Article ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 5 – 6]] || IVD || EN || 5. In the case of PMPF studies referred to in Article 70(1), the provisions on vigilance laid down in Articles 82 to 85 and in the implementing acts adopted pursuant to Article 86 shall apply instead ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 82 Paragraph 3 – 5]] || IVD || EN || Reporting of serious incidents and field safety corrective actions 3. Manufacturers shall report any serious incident as referred to in point (a) immediately after they have established a causal ...
|}

===== 5.3.6 — National requirements =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 6-002]] || HM || DE || § 40b Besondere Voraussetzungen für die klinische Prüfung (6) Die betroffene Person oder, falls diese nicht in der Lage ist, eine Einwilligung nach Aufklärung zu erteilen, ihr gesetzlicher Vertreter ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-003]] || HM || DE || § 40d Besondere Pflichten des Prüfers, des Sponsors und der zuständigen Bundesoberbehörde Bei klinischen Prüfungen mit Arzneimitteln, die aus einem gentechnisch veränderten Organismus oder einer ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 63]] || MD || DE || § 63 Meldepflichten des Prüfers oder Hauptprüfers (1) Der Prüfer oder Hauptprüfer meldet dem Sponsor einer klinischen Prüfung oder sonstigen klinischen Prüfung 1. unverzüglich a) jedes schwerwiegende ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 64]] || MD || DE || § 64 Melde- und Mitteilungspflichten des Sponsors bei einer sonstigen klinischen Prüfung (1) Der Sponsor meldet über das Deutsche Medizinprodukteinformations- und Datenbanksystem nach § 86 der ...
|-
| [[Reference:AUT MPG – Medizinproduktegesetz 26-May-2022 § 22]] || MD || DE || Unerwünschte Ereignisse § 22. Die Meldungen gemäß Art. 80 Abs. 2 der Verordnung (EU) Nr. 745/2017 oder Art. 76 Abs. 2 der Verordnung (EU) Nr. 746/2017 sind vom Sponsor auch der beurteilenden ...
|-
| [[Reference:FRA AEC_DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 3.]] || MD || FR || 3. RAPPORT ANNUEL DE SECURITE Bien que le RDM ne le prévoie pas, il est demandé pour les RIPH1 portant sur un DM se poursuivant après le 26 mai 2021 de continuer à appliquer les dispositions de la ...
|-
| [[Reference:FRA AEC_DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-001]] || MD || FR || 2. DECLARATION DES FAITS NOUVEAUX ET MESURES URGENTES DE SECURITE Bien que le RDM ne le prévoie pas, il est demandé pour les RIPH1 portant sur un DM se poursuivant après le 26 mai 2021 de continuer à ...
|-
| [[Reference:FRA SURV_VIG_DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025 5.]] || HM || FR || 5. AUTRES OBLIGATIONS DE NOTIFICATION DE DONNEES DE SECURITE POUR LES PROMOTEURS CONDUISANT DES ESSAIS CHEZ LES VOLONTAIRES SAINS EN FRANCE 5.1. Dispositions du code de la santé publique Conformément ...
|-
| [[Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-46]] || G || FR || Article R1123-46 Pour l'application de la présente section, on entend par : […] 12° Pour les recherches impliquant la personne humaine, fait nouveau : toute nouvelle donnée pouvant conduire à une ...
|-
| [[Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-53]] || G || FR || Article R1123-53 Pour les recherches mentionnées au 1° de l'article L. 1121-1 autres que celles mentionnées aux articles R. 1123-54 à R. 1123-58, le promoteur déclare à l'autorité compétente toute ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 33]] || HM || EN || Notification of suspected unexpected serious adverse reactions 33.—(1) A sponsor shall ensure that all relevant information about a suspected unexpected serious adverse reaction which occurs during ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 34]] || HM || EN || Clinical trials conducted in third countries 34. If a clinical trial is being conducted at a trial site in a third country in addition to sites in the United Kingdom, the sponsor of that trial shall ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 35]] || HM || EN || Annual list of suspected serious adverse reactions and safety report 35.—(1) As soon as practicable after the end of the reporting year, a sponsor shall, in relation to each investigational medicinal ...
|-
| [[Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 17]] || HM || EN || Notification of serious adverse reactions 1.(a)The sponsor shall ensure that all relevant information about suspected serious unexpected adverse reactions that are fatal or life-threatening is ...
|-
| [[Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X]] || MD || EN || CLINICAL EVALUATION […] 2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being ...
|-
| [[Reference:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 2.-002]] || MD || EN || 2. Clinical Investigation Plan [….] Description of procedures and details of data to record and report serious adverse events and adverse device related incidents (in line with requirements in MEDDEV ...
|-
| [[Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-002]] || MD || EN || 8 Reporting timelines 8.1 Report by sponsor to NCAs. The sponsor must report to all NCAs where the clinical investigation is authorised to start: • For all reportable events as described in section 5 ...
|-
| [[Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 4]] || MD || EN || CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC 4. REPORTABLE EVENTS UNDER ANNEX 7 AND ANNEX X OF DIRECTIVES 90/385/EEC AND 93/42/EEC RESPECTIVELY ...
|-
| [[Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 5 - 6]] || MD || EN || CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC 5. REPORT BY WHOM. Reportable events have to be reported by the sponsor of the clinical ...
|-
| [[Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.1]] || MD || EN || 7. REPORTING TIMELINES 7.1 Report by sponsor to NCAs. The sponsor must report to the NCAs where the clinical investigation has commenced: - for all reportable events as described in section 4 which ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 (b)]] || HM || EN || (b) Review of safety information. The sponsor must promptly review all information relevant to the safety of the drug obtained or otherwise received by the sponsor from foreign or domestic sources, ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 (c)]] || HM || EN || (c) (1) IND safety reports. The sponsor must notify FDA and all participating investigators (i.e., all investigators to whom the sponsor is providing drug under its INDs or under any investigator's ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 (d)]] || HM || EN || (d) Followup. (1) The sponsor must promptly investigate all safety information it receives. (2) Relevant followup information to an IND safety report must be submitted as soon as the information is ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) - (b)]] || HM || EN || § 312.33 Annual reports. A sponsor shall within 60 days of the anniversary date that the IND went into effect, submit a brief report of the progress of the investigation that includes: (a) Individual ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (b) (5)]] || MD || EN || § 812.140 Records. […] (b) Sponsor records.[...] (5) Records concerning adverse device effects (whether anticipated or unanticipated) and complaints [...]
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (1)]] || MD || EN || § 812.150 Reports. (b) Sponsor reports. [...] (1) Unanticipated adverse device effects. A sponsor who conducts an evaluation of an unanticipated adverse device effect under § 812.46(b) shall report ...
|-
| [[Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; Evaluation]] || G || EN || [...] For clinical investigations of drug and biological products conducted under an investigational new drug (IND) application, information about adverse events5 must be communicated among ...
|-
| [[Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.4]] || G || EN || 1.4 Sponsor Responsibility • It is the responsibility of the sponsor to submit an IND/IDE for clinical trials conducted with investigational agents/interventions subject to FDA 21 CFR 312 and 21 CFR ...
|}

==== Imminent danger - corrective measures ====

===== 5.4.1 — Imminent danger for the participant & withdrawal =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.1-002]] || G || EN || 2.7.1 Medical Care of Trial Participants (a) A qualified physician or, where appropriate, a qualified dentist (or other qualified healthcare professionals in accordance with local regulatory ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) Appendix A 3.4]] || G || EN || A.3 Contents of the Investigator’s Brochure [...] A.3.4 Physical, Chemical and Pharmaceutical Properties and Formulation A description should be provided of the investigational product substance(s) ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-001]] || G || EN || B.4 Trial Design […] B.4.8 A description of the “stopping rules” or “discontinuation criteria” and “dose adjustment” or “dose interruption” for individual participants, for parts of the trial or for ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-002]] || G || EN || B.6 Discontinuation of Trial Intervention and Participant Withdrawal from Trial The investigator may choose to discontinue the participant from the trial. Conversely, the participant may decide to ...
|-
| [[Reference:ICH ICH E9 Guideline 1998 Glossary - Dropout]] || HM || EN || Dropout A subject in a clinical trial who for any reason fails to continue in the trial until the last visit required of him/her by the study protocol.
|-
| [[Reference:ICH ICH E8 Guideline R1 (2021) 6.2.2]] || HM || EN || 6.2.2 Withdrawal Criteria Clear criteria for stopping treatment or study procedures for a study participant while remaining in the study are necessary to ensure the protection of the participants but ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - immediate hazard]] || HM || EN || [...] The investigator should not make any changes in the study without the agreement of the sponsor, except when necessary to eliminate an apparent immediate hazard or danger to a trial subject. ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.6]] || HM || EN || 4.6 The investigational product The investigator must be thoroughly familiar with the properties, effects and safety of the investigational pharmaceutical product(s), including pre-trial data, as ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-002]] || MD || EN || A.6.3 Subjects a) Inclusion criteria[…]
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 30-001]] || HM || EN || Urgent safety measures 30.—(1) The sponsor and investigator may take appropriate urgent safety measures in order to protect the subjects of a clinical trial against any immediate hazard to their ...
|-
| [[Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-001]] || HM || EN || Conduct of a clinical trial […] (b)without prejudice to point (a), in the light of the circumstances, notably the occurrence of any new event relating to the conduct of the trial or the development ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.30 (b) (ii)]] || HM || EN || § 312.30 Protocol amendments […] (b) Changes in a protocol. […] (ii) Notwithstanding paragraph (b)(2)(i) of this section, a protocol change intended to eliminate an apparent immediate hazard to ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (4)]] || MD || EN || § 812.150 Reports. (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: (4) Deviations from the investigational plan. An ...
|}

===== 5.4.2 — Imminent danger - for all participants =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-002]] || G || EN || B.4 Trial Design […] B.4.8 A description of the “stopping rules” or “discontinuation criteria” and “dose adjustment” or “dose interruption” for individual participants, for parts of the trial or for ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.46]] || MD || EN || serious health threat […]
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-002]] || MD || EN || 7.4.3 Device deficiencies […]
|}

===== 5.4.3 — Corrective measures =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 54]] || HM || EN || Urgent safety measures 1. Where an unexpected event is likely to seriously affect the benefit-risk balance, the sponsor and the investigator shall take appropriate urgent safety measures to protect ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 77]] || HM || EN || Corrective measures to be taken by Member States 1. Where a Member State concerned has justified grounds for considering that the requirements set out in this Regulation are no longer met, it may ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 6]] || MD || EN || Conduct of a clinical investigation 6. The sponsor shall establish a procedure for emergency situations which enables the immediate identification and, where necessary, an immediate recall of the ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 76]] || MD || EN || Corrective measures to be taken by Member States and information exchange between Member States 1. Where a Member State in which a clinical investigation is being or is to be conducted has grounds ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77]] || MD || EN || Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination 1. [...] In the event that the sponsor has temporarily halted or ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 1]] || IVD || EN || Conduct of a performance study 1. The sponsor and the investigator shall ensure that the performance study is conducted in accordance with the approved performance study plan.
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b)]] || MD || EN || § 812.46 Monitoring investigations […] (b) Unanticipated adverse device effects. (1) A sponsor shall immediately conduct an evaluation of any unanticipated adverse device effect. (2) A sponsor who ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42]] || HM || DE || § 42 Korrekturmaßnahmen (1) Die zuständige Bundesoberbehörde ergreift die in Artikel 77 der Verordnung (EU) Nr. 536/2014 genannten Korrekturmaßnahmen nach Maßgabe der folgenden Absätze. (2) Die ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 66]] || MD || DE || § 66 Eigenverantwortliche korrektive Maßnahmen (1) Treten während einer klinischen Prüfung, einer Leistungsstudie nach Artikel 58 Absatz 1 oder Absatz 2 Satz 1 der Verordnung (EU) 2017/746 oder einer ...
|-
| [[Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 11]] || G || DE || § 11 Korrekturmaßnahmen Die zuständige Bundesoberbehörde informiert die zuständige Ethik-Kommission über beabsichtigte Korrekturmaßnahmen nach § 42 Absatz 2 bis 4 des Arzneimittelgesetzes. Die ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 30-002]] || HM || EN || Urgent safety measures 30.—(1) The sponsor and investigator may take appropriate urgent safety measures in order to protect the subjects of a clinical trial against any immediate hazard to their ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 31]] || HM || EN || Suspension or termination of clinical trial 31.—(1) If, in relation to a clinical trial— (a)the licensing authority have objective grounds for considering that— (i)any condition, restriction or ...
|-
| [[Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-002]] || HM || EN || Conduct of a clinical trial […] (b)without prejudice to point (a), in the light of the circumstances, notably the occurrence of any new event relating to the conduct of the trial or the development ...
|-
| [[Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 6. - 7.-001]] || MD || EN || Clinical Investigation [...] 6. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.44 (d)]] || HM || EN || § 312.44 Termination. […] (d) Immediate termination of IND (d) Immediate termination of IND. Notwithstanding paragraphs (a) through (c) of this section, if at any time FDA concludes that continuation ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.56]] || HM || EN || § 312.56 Review of ongoing investigations. […] (d) A sponsor who determines that its investigational drug presents an unreasonable and significant risk to subjects shall discontinue those ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.7 (c)]] || MD || EN || § 812.7 Prohibition of promotion and other practices. A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not: […] (c) Unduly prolong an investigation. ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.30 (b) - (c)]] || MD || EN || § 812.30 FDA action on applications [...] (b) Grounds for disapproval or withdrawal. FDA may disapprove or withdraw approval of an application if FDA finds that: (1) There has been a failure to ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) - (c)-001]] || MD || EN || § 812.46 Monitoring investigations. […] (b) Unanticipated adverse device effects. (1) A sponsor shall immediately conduct an evaluation of any unanticipated adverse device effect. (2) A sponsor who ...
|-
| [[Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.113-001]] || G || EN || § 56.113 Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's ...
|}

===== 5.4.4 — Contraception and pregnancy =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E8 Guideline R1 (2021) 4.3.3.1]] || HM || EN || 4.3.3.1 Investigations in pregnant women Investigation of drugs that may be used in pregnancy is important. Where pregnant women volunteer to be enrolled in a clinical study, or a participant becomes ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 9.4]] || G || EN || B.9.4 The type and duration of the follow-up of participants after adverse events and other events such as pregnancies.
|-
| [[Reference:EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005 2.1]] || HM || EN || 2.1 Background The majority of medicinal products or chemical substances administered to a pregnant woman could have effects on the foetus either before the placenta is fully developed or ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX III Section 2.1]] || HM || EN || Adverse Events and Causality 2. Medication errors, pregnancies and uses outside what is foreseen in the protocol, including misuse and abuse of the product, shall be subject to the same obligation to ...
|-
| [[Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.6.6.1]] || G || EN || 5.6.6.1 Pregnancy • Although not an AE in and of itself, pregnancy as well as its outcome must be documented via CTEP-AERS. CTEP agrees to soliciting information about pregnancy outcomes only from ...
|}

==== Insurances ====

=== Module 6: Completion of the clinical trial ===

==== End, premature termination or halt of a trial ====

===== 6.1.1 — Definitions =====

===== 6.1.2 — Requirements =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.6]] || G || EN || 2. INVESTIGATOR [...] 2.6 Premature Termination or Suspension of a Trial 2.6.1 If the trial is prematurely terminated or suspended for any reason, the investigator/institution should promptly inform ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.17.1]] || G || EN || 3. SPONSOR [...] 3.17.1Premature Termination or Suspension of a Trial If a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigators/institutions and the ...
|-
| [[Reference:ICH ICH E9 Guideline 1998 4.5]] || HM || EN || 4.5 Interim Analysis and Early Stopping An interim analysis is any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to formal completion of a trial. ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.15]] || HM || EN || 4.15 Termination of trial In the case of premature termination of the clinical trial, the investigator must inform the drug regulatory authority, the ethics committee and, where applicable, the ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.14]] || HM || EN || 5.14 Termination of trial If the sponsor elects or is required to terminate the clinical trial prematurely, then the investigator(s), ethics committee and relevant authorities must be notified of ...
|-
| [[Reference:WMA Declaration of Helsinki 2024 34]] || G || EN || Post-Trial Provisions 34. In advance of a clinical trial, post-trial provisions must be arranged by sponsors and researchers to be provided by themselves, healthcare systems, or governments for all ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 8.2]] || MD || EN || 8.2 Suspension or premature termination of the clinical investigation 8.2.1 Procedure for suspension or premature termination [...] 8.2.2 Procedure for resuming the clinical investigation after ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 26 - 29]] || HM || EN || (26) ‘End of a clinical trial’ means the last visit of the last subject, or at a later point in time as defined in the protocol; (27) ‘Early termination of a clinical trial’ means the premature end ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 37 Paragraph 1 – 7]] || HM || EN || End of a clinical trial, temporary halt and early termination of a clinical trial and submission of the results 1. The sponsor shall notify each Member State concerned of the end of a clinical trial ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 38]] || HM || EN || Temporary halt or early termination by the sponsor for reasons of subject safety 1. For the purposes of this Regulation, the temporary halt or early termination of a clinical trial for reasons of a ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 76 Paragraph 3]] || MD || EN || Corrective measures to be taken by Member States and information exchange between Member States 3. Where a Member State has taken a measure referred to in paragraph 1 of this Article or has refused a ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 1 – 3]] || MD || EN || Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination 1. If the sponsor has temporarily halted a clinical investigation or has ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 5]] || MD || EN || 5. Irrespective of the outcome of the clinical investigation, within one year of the end of the clinical investigation or within three months of the early termination or temporary halt, the sponsor ...
|-
| [[Reference:FRA AEC_DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-002]] || MD || FR || 2. DECLARATION DES FAITS NOUVEAUX ET MESURES URGENTES DE SECURITE Bien que le RDM ne le prévoie pas, il est demandé pour les RIPH1 portant sur un DM se poursuivant après le 26 mai 2021 de continuer à ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. (p)]] || HM || EN || 1. An application document including the following information or, in each case, an explanation of why that information is not being provided— […] (p)the rules for terminating or concluding the trial ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 27]] || HM || EN || Conclusion of clinical trial 27.—(1) Subject to paragraph (2), within 90 days of the conclusion of a clinical trial the sponsor shall notify the licensing authority and the relevant ethics committee ...
|-
| [[Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 5 (5)]] || HM || EN || PROCEDURAL PROVISIONS RELATING TO THE REFUSAL OR AMENDMENT OF, OR IMPOSITION OF CONDITIONS RELATING TO, CLINICAL TRIAL AUTHORISATION AND THE SUSPENSION OR TERMINATION OF CLINICAL TRIALS 1.— […] (5) ...
|-
| [[Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (c)]] || HM || EN || Conduct of a clinical trial […] (c)within 90 days of the end of a clinical trial the sponsor shall notify the competent authorities of the Member State or Member States concerned and the Ethics ...
|-
| [[Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 16 (11)]] || MD || EN || Procedures for general medical devices for clinical investigations 16.— […] (11) The manufacturer, or their single authorised representative, shall— (a)notify the Secretary of State of the end of the ...
|-
| [[Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 6. - 7.-002]] || MD || EN || Clinical Investigation [...] 6. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a ...
|-
| [[Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.113-002]] || G || EN || § 56.113 Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's ...
|-
| [[Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.113]] || G || EN || § 46.113 Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's ...
|-
| [[Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.123]] || G || EN || § 46.123 Early termination of research support: Evaluation of applications and proposals. (a) The department or agency head may require that Federal department or agency support for any project be ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.38]] || HM || EN || § 312.38 Withdrawal of an IND. (a) At any time a sponsor may withdraw an effective IND without prejudice. (b) If an IND is withdrawn, FDA shall be so notified, all clinical investigations conducted ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.42]] || HM || EN || § 312.42 Clinical holds and requests for modification. (a) General. A clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.44]] || HM || EN || § 312.44 Termination. (a) General […] (b) Grounds for termination — […] (c) Opportunity for sponsor response. […] (d) Immediate termination of IND […]
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.45]] || HM || EN || § 312.45 Inactive status. (a) If no subjects are entered into clinical studies for a period of 2 years or more under an IND, or if all investigations under an IND remain on clinical hold for 1 year ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (q)]] || MD || EN || (q) Termination means a discontinuance, by sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion.
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b) - (c)-002]] || MD || EN || § 812.46 Monitoring investigations […] (b) Unanticipated adverse device effects. […] (c) Resumption of terminated studies. If the device is a significant risk device, a sponsor may not resume a ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (2)]] || MD || EN || § 812.150 Reports. (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: (2) Withdrawal of IRB approval. An investigator shall ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (1) - (3)]] || MD || EN || § 812.150 Reports. (b) Sponsor reports. [...] (2) Withdrawal of IRB approval. A sponsor shall notify FDA and all reviewing IRB's and participating investigators of any withdrawal of approval of an ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (7)-001]] || MD || EN || § 812.150 Reports. (b) Sponsor reports. [...] (7) Final report. In the case of a significant risk device, the sponsor shall notify FDA within 30 working days of the completion or termination of the ...
|}

==== Close Out Visit ====

==== Archiving ====

===== 6.3.1 — Requirements =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) Appendix C 2]] || G || EN || Appendix C. ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL [...] C.2 Management of Essential Records [...] C.2.4 The sponsor and investigator/institution should maintain a record of where ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 14.3]] || G || EN || Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) [...] B.14 Data Handling and Record Keeping [...] B.14.3 A statement that records should be retained in accordance with applicable ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8.3]] || HM || EN || 8.3 Archiving of data As required by national regulations, the investigator must arrange for the retention of the subject identification codes for a sufficient period of time to permit any medical ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 58]] || HM || EN || Archiving of the clinical trial master file Unless other Union law requires archiving for a longer period, the sponsor and the investigator shall archive the content of the clinical trial master file ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 3 – 4-002]] || MD || EN || Conduct of a clinical investigation 3. All clinical investigation information shall be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that it ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III 1. ; 3.]] || MD || EN || OTHER OBLIGATIONS OF THE SPONSOR 1. The sponsor shall undertake to keep available for the competent national authorities any documentation necessary to provide evidence for the documentation referred ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 3 – 4-002]] || IVD || EN || Conduct of a performance study 3. All performance study information shall be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that it can be ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 3-002]] || IVD || EN || OTHER OBLIGATIONS OF THE SPONSOR 3. The documentation mentioned in this Annex shall be kept for a period of time of at least 10 years after the clinical performance study with the device in question ...
|-
| [[Reference:DEU AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung 09-Aug-2019 § 20]] || HM || DE || § 20 Aufbewahrung der Dokumentation (1) 1Alle Aufzeichnungen über den Erwerb, die Herstellung einschließlich der Freigabe, die Prüfung, Lagerung, das Verbringen in den oder aus dem Geltungsbereich ...
|-
| [[Reference:DEU BGB - Bürgerliches Gesetzbuch 22-Dec-2023 § 630]] || G || DE || § 630 Pflicht zur Zeugniserteilung Bei der Beendigung eines dauernden Dienstverhältnisses kann der Verpflichtete von dem anderen Teil ein schriftliches Zeugnis über das Dienstverhältnis und dessen ...
|-
| [[Reference:DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 § 10 Absatz 3]] || G || DE || § 10 Dokumentationspflicht (3) Ärztliche Aufzeichnungen sind für die Dauer von zehn Jahren nach Abschluss der Behandlung aufzubewahren, soweit nicht nach gesetzlichen Vorschriften eine längere ...
|-
| [[Reference:DEU Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form 01-Mar-2021 -]] || G || DE || https://www.bundestag.de/resource/blob/858466/8c44dd9b4dfc7f144f94db82693c8dba/WD-9-015-21-pdf-data.pdf
|-
| [[Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.6]] || NIS || DE || 2.7.6. Berichte und Archivierung Ergebnisse von Anwendungsbeobachtungen sollten nach wissenschaftlichen Kriterien publiziert werden. Es wird empfohlen, alle Unterlagen einer Anwendungsbeobachtung für ...
|-
| [[Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 8]] || NIS || DE || Leitlinie 8 (Auswertung epidemiologischer Daten) Die Auswertung epidemiologischer Studien soll unter Verwendung adäquater Methoden und ohne unangemessene Verzögerung erfolgen. Die den Ergebnissen ...
|-
| [[Reference:AUT Ärztegesetz 08-Mar-2023 § 51 (3)]] || G || DE || Die Aufzeichnungen sowie die sonstigen der Dokumentation im Sinne des Abs. 1 dienlichen Unterlagen sind mindestens zehn Jahre aufzubewahren.
|-
| [[Reference:FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007 2.1]] || G || FR || Instruction interministérielle DHOS/E1/DAF/DPACI no 2007-322 et (no DAF/DPACI/RES/no 2007-014) du 14 août 2007 relative à la conservation du dossier médical NOR : SJSH0730928J [...] 2.1. Les nouveaux ...
|-
| [[Reference:FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007 2.1.2]] || G || FR || 2.1.2. Cette durée de conservation connaît des aménagements L’article R. 1112-7 du code de la santé publique prévoit divers aménagements des durées de conservation des dossiers médicaux. Par ...
|-
| [[Reference:GBR NHS: Records Management Code of Practice 07-Aug-2023 -]] || G || EN || Record type: Advanced medical therapy research: master file Category: Clinical Trials and Research Retention period: 20 years Disposal action: Review and consider transfer to PoD (Place of Deposit) ...
|-
| [[Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.6]] || G || EN || § 54.6 Recordkeeping and record retention. (a) Financial records of clinical investigators to be retained. An applicant who has submitted a marketing application containing covered clinical studies ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.57-002]] || HM || EN || § 312.57 Recordkeeping and record retention. (a) A sponsor shall maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug. These records are required ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (c)]] || HM || EN || § 312.62 Investigator recordkeeping and record retention. [...] (c) Record retention. An investigator shall retain records required to be maintained under this part for a period of 2 years following ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (d)]] || MD || EN || § 812.140 Records. […] (d) Retention period. An investigator or sponsor shall maintain the records required by this subpart during the investigation and for a period of 2 years after the latter of ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (e)]] || MD || EN || § 812.140 Records. […] (e) Records custody. An investigator or sponsor may withdraw from the responsibility to maintain records for the period required in paragraph (d) of this section and transfer ...
|-
| [[Reference:USA 45 CFR Part 160 09-Apr-2025 § 164.526]] || G || EN || § 164.526 Amendment of protected health information. […] (4) Recordkeeping. The covered entity must, as appropriate, identify the record or protected health information in the designated record set ...
|-
| [[Reference:USA 45 CFR Part 160 09-Apr-2025 § 164.530]] || G || EN || § 164.530 Administrative requirements. […] (i) (1) Standard: Policies and procedures. A covered entity must implement policies and procedures with respect to protected health information that are ...
|}

==== Interim Reports and Final Reports ====

===== 6.4.1 — Interim ClinicalTrial/Study reports =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Interim Clinical Trial/Study Report]] || G || EN || Interim Clinical Trial/Study Report A report of intermediate results and their evaluation based on analyses performed during the course of a trial.
|-
| [[Reference:ICH ICH E8 Guideline R1 (2021) 6.1.4]] || HM || EN || 6.1.4 Access to Interim Data Inappropriate access to data during the conduct of the study may compromise study integrity (Sections 5.5 and 5.6 and ICH E9). In studies with planned interim analyses, ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.12]] || HM || EN || 5.12 Study reports The sponsor is responsible for ensuring the preparation and appropriate approval(s) of a comprehensive final clinical study report suitable for regulatory purposes, whether or not ...
|-
| [[Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3.1]] || NIS || EN || VIII.B.4.3. Study reports VIII.B.4.3.1. Progress report and interim report of study results The progress report is meant to include relevant information to document the progress of the study, for ...
|-
| [[Reference:AUT Question - BASG 11-Feb-2025 -]] || G || DE || Q: Muss jährlich eine Bestätigung von der Ethikkommission eingeholt werden, dass die klinische Prüfung fortgesetzt werden kann? A: Dafür gibt es keine gesetzliche Grundlage, kann aber von den ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.33]] || HM || EN || § 312.33 Annual reports. A sponsor shall within 60 days of the anniversary date that the IND went into effect, submit a brief report of the progress of the investigation that includes: […]
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64-002]] || HM || EN || § 312.64 Investigator reports. (a) Progress reports. The investigator shall furnish all reports to the sponsor of the drug who is responsible for collecting and evaluating the results obtained. The ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.36]] || MD || EN || § 812.36 Treatment use of an investigational device. (a) General. A device that is not approved for marketing may be under clinical investigation for a serious or immediately life-threatening disease ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (3)]] || MD || EN || § 812.150 Reports. (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: (3) Progress. An investigator shall submit progress reports ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (5)]] || MD || EN || § 812.150 Reports. (b) Sponsor reports. [...] (5) Progress reports. At regular intervals, and at least yearly, a sponsor shall submit progress reports to all reviewing IRB's. In the case of a ...
|}

===== 6.4.2 — Final report =====
{| class="wikitable"
! Reference !! Scope !! Language !! Preview
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Clinical Trial/Study Report (CSR)]] || G || EN || Clinical Trial/Study Report (CSR) A documented description of a trial of any investigational product conducted in human participants, in which the clinical and statistical description, presentations ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.13]] || G || EN || 2. INVESTIGATOR [...] 2.13 Reports Upon completion of the trial, the investigator, where applicable, should inform the institution. The investigator/institution should provide the IRB/IEC with a ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 3.17.2]] || G || EN || 3. SPONSOR […] 3.17.2 Clinical Trial/Study Reports (a) Whether the trial is completed or prematurely terminated, or an interim analysis is undertaken for regulatory submission, the sponsor should ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.10.1.6]] || G || EN || 3.10.1.6 Risk Reporting The sponsor should summarise and report important quality issues (including instances in which acceptable ranges are exceeded, as detailed in section 3.10.1.3) and the ...
|-
| [[Reference:ICH ICH E3 Guideline 1995 -]] || G || EN || STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - final report]] || HM || EN || final report A comprehensive description of the trial after its completion including a description of experimental methods (including statistical methods) and materials, a presentation and evaluation ...
|-
| [[Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.16]] || HM || EN || 4.16 Final report After completion of the trial, a final report must be drawn up and submitted to the drug regulatory authority. The report should be dated and signed by the investigator in ...
|-
| [[Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex D]] || MD || EN || Clinical investigation report D.1 General [...]
|-
| [[Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Final report]] || G || EN || 23. [...] After the end of the research, the researchers must submit a final report to the committee containing a summary of the findings and conclusions.
|-
| [[Reference:N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008 -]] || INS || EN || von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)statement: guidelines for ...
|-
| [[Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 37 Paragraph 4]] || HM || EN || End of a clinical trial, temporary halt and early termination of a clinical trial and submission of the results 4. Irrespective of the outcome of a clinical trial, within one year from the end of a ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 4 – 5]] || MD || EN || 4. If an investigation is conducted in more than one Member State, the sponsor shall notify all Member States in which that clinical investigation was conducted of the end of the clinical ...
|-
| [[Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 6 – 7]] || MD || EN || 6. The Commission shall issue guidelines regarding the content and structure of the summary of the clinical investigation report. In addition, the Commission may issue guidelines for the formatting ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 73 Paragraph 5]] || IVD || EN || Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination 5. Irrespective of the outcome of the performance study, within one year of the ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 77 Paragraph 4 – 5]] || IVD || EN || 4. If a study is conducted in more than one Member State, the sponsor shall notify all Member States in which that performance study was conducted of the end of the performance study in all Member ...
|-
| [[Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 77 Paragraph 6 – 7]] || IVD || EN || 6. The Commission shall issue guidelines regarding the content and structure of the summary of the performance study report. In addition, the Commission may issue guidelines for the formatting and ...
|-
| [[Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 2. ; 3.]] || G || EN || ANNEX III Protocols, abstracts and final study reports for post-authorisation safety studies [...] 2. Format of the abstract of the final study report [...] 3. Format of the final study report [...]
|-
| [[Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3]] || NIS || EN || VIII.B.4.3. Study reports [...] VIII.B.4.3.2. Final study report [...]
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42b]] || HM || DE || § 42b Veröffentlichung der Ergebnisse klinischer Prüfungen (1) Pharmazeutische Unternehmer, die im Geltungsbereich dieses Gesetzes ein Arzneimittel in den Verkehr bringen, das der Pflicht zur ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-003]] || MD || DE || § 62 Pflichten des Prüfers oder Hauptprüfers (1) Der Prüfer oder Hauptprüfer stellt sicher, dass 1. die klinische Prüfung, die Leistungsstudie oder sonstige klinische Prüfung durchgeführt wird in ...
|-
| [[Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 64 Absatz 3]] || MD || DE || § 64 Melde- und Mitteilungspflichten des Sponsors bei einer sonstigen klinischen Prüfung (3) Zwölf Monate nach Beendigung der sonstigen klinischen Prüfung legt der Sponsor der zuständigen ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63f (4)]] || NIS || DE || § 63f Allgemeine Voraussetzungen für nichtinterventionelle Unbedenklichkeitsstudien [...] Innerhalb eines Jahres nach Abschluss der Datenerfassung sind unter Angabe der insgesamt beteiligten Ärzte ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63g (4)]] || NIS || DE || § 63g Besondere Voraussetzungen für angeordnete nichtinterventionelle Unbedenklichkeitsstudien [...] (4) Nach Abschluss einer Studie nach Absatz 1 ist der abschließende Studienbericht 1. in den ...
|-
| [[Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 67 (6) - NIS]] || NIS || DE || § 67 Allgemeine Anzeigepflicht […] Innerhalb eines Jahres nach Abschluss der Datenerfassung sind unter Angabe der insgesamt beteiligten Ärzte die Anzahl der jeweils und insgesamt beteiligten ...
|-
| [[Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.2.1 - Start]] || NIS || DE || 2.2.1. Anzeigeinhalte gegenüber den Bundesoberbehörden Anwendungsbeobachtungen sind nach § 67 Absatz 6 AMG gegenüber der zuständigen Bundesoberbehörde unverzüglich anzuzeigen. Dabei sind Ort, Zeit, ...
|-
| [[Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.3.7]] || MD || EN || 2.3.7. The written report, signed by the medical practitioner or other authorized person responsible, must contain a critical evaluation of all the data collected during the clinical investigation.
|-
| [[Reference:GBR HRA - Ending your project 28-Jan-2025 -]] || G || EN || HRA (England) website: https://www.hra.nhs.uk/approvals-amendments/managing-your-approval/ending-your-project/ Final report on the research Once you have declared the end of study, and notified the ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64 (c) - (d)]] || HM || EN || § 312.64 Investigator reports. [...] (c) Final report. An investigator shall provide the sponsor with an adequate report shortly after completion of the investigator's participation in the ...
|-
| [[Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) (3)]] || HM || EN || § 312.33 Annual reports. A sponsor shall within 60 days of the anniversary date that the IND went into effect, submit a brief report of the progress of the investigation that includes: […] (a) […] ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (6)]] || MD || EN || § 812.150 Reports. (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: [...] (6) Final report. An investigator shall, within 3 ...
|-
| [[Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (7)-002]] || MD || EN || § 812.150 Reports. (b) Sponsor reports. [...] (7) Final report. In the case of a significant risk device, the sponsor shall notify FDA within 30 working days of the completion or termination of the ...
|-
| [[Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.40]] || G || EN || § 11.40 Who must submit clinical trial results information? The responsible party for an applicable clinical trial specified in § 11.42 must submit clinical trial results information for that ...
|-
| [[Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.44]] || G || EN || § 11.44 When must clinical trial results information be submitted for applicable clinical trials subject to § 11.42? (a) Standard submission deadline. In general, for applicable clinical trials ...
|-
| [[Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.54]] || G || EN || § 11.54 What are the procedures for requesting and obtaining a waiver of the requirements for clinical trial results information submission? […]
|}

==== Publication ====

=== Module 7: Use of AI ===

=== Module 8: GCP course programm recommendations ===