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• Reference:GBR NHS: Records Management Code of Practice 07-Aug-2023 -  + (Record type: Advanced medical therapy research: master file Category: Clinical Trials and Research Retention period: 20 years Disposal action: Review …)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 2 – 3  + (Recording and reporting of adverse events that occur during performance studies 2. The sponsor shall report without delay to all Member States in w…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 1-2  + (Recording and reporting of adverse events that occur during clinical investigations 1. The sponsor shall fully record all of the following: (a) any…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 1  + (Recording and reporting of adverse events that occur during performance studies 1. The sponsor shall fully record all of the following: (a) any ad…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 56  + (Recording, processing, handling and storage of information 1. All clinical trial information shall be recorded, processed, handled, and stored by t…)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Regulatory Authorities  + (Regulatory Authorities Bodies having the power to regulate, including those that review submitted protocols and clinical data and those that conduct …)
• Reference:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 -  + (Remote direct access to Electronic Health Records (EHR) by Sponsor Monitors (or Auditors) in clinical trials [...] Remote direct access to the health …)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-001  + (Reporting of adverse events and serious adverse events by the investigator to the sponsor 1. The investigator shall record and document adverse eve…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 41-002  + (Reporting of adverse events and serious adverse events by the investigator to the sponsor 1. The investigator shall record and document adverse eve…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 52  + (Reporting of serious breaches 1. The sponsor shall notify the Member States concerned about a serious breach of this Regulation or of the version o…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 82 Paragraph 3 – 5  + (Reporting of serious incidents and field safety corrective actions 3. Manufacturers shall report any serious incident as referred to in point (a) i…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 87 Paragraph 1 – 2  + (Reporting of serious incidents and field safety corrective actions 1. Manufacturers of devices made available on the Union market, other than inves…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 42  + (Reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency 1. The sponsor of a clinical trial performed in at least o…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 17  + (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 a…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 82  + (Requirements regarding other clinical investigations 1. Clinical investigations, not performed pursuant to any of the purposes listed in Article 62…)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 23  + (Research Ethics Committees 23. The protocol must be submitted for consideration, comment, guidance, and approval to the concerned research ethics com…)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Amendment approval  + (Research Ethics Committees 23. […] No amendment to the protocol may be made without consideration and approval by the committee. [...]…)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Oversight  + (Research Ethics Committees 23. […] The committee must have the right to monitor, recommend changes to, withdraw approval for, and suspend ongoing res…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 13  + (Resubmission This Chapter is without prejudice to the possibility for the sponsor to resubmit, following the refusal to grant an authorisation or the…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 16  + (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…)
• Reference:DEU Richtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen von Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. und  + (Richtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen vo…)
• Reference:N.A. SPIRIT 2013 - Chan et al. 2013 -  + (SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials Publication: Annals of Internal Medicine ; Volume 158, Number 3 https://ww…)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex VIII 1. ; 2.  + (STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES 1.For custom-made devices or for devices intended for clinical investigations the manufacturer or hi…)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex VIII 1. ; 2. ; 2.2  + (STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES 1.For custom-made devices or for devices intended for clinical investigations the manufacturer or hi…)
• Reference:ICH ICH E9 Guideline - Addendum R1 20-Nov-2019 -  + (STATISTICAL PRINCIPLES FOR CLINICAL TRIALS E9 ADDENDUM ON ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS TO THE GUIDELINE ON STATISTICAL PRIN…)

• Reference:ICH ICH E3 Guideline 1995 -  + (STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS…)

• Reference:ICH ICH E7 Guideline 1993 -  + (STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS…)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 22  + (Scientific Requirements and Research Protocols [...] 22. The design and performance of all medical research involving human participants must be clear…)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Serious Adverse Event (SAE)  + (Serious Adverse Event (SAE): Any unfavourable medical occurrence that is considered serious at any dose if it: • Results in death, • Is life-threaten…)
• Reference:ICH ICH E2A Guideline 1994 II B. Serious Adverse Event or Adverse Drug Reaction  + (Serious Adverse Event or Adverse Drug Reaction During clinical investigations, adverse events may occur which, if suspected to be medicinal product-re…)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - SAE  + (Serious adverse event or serious suspected adverse reaction. An adverse event or suspected adverse reaction is considered “serious” if, in the view of…)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Service Provider  + (Service Provider A person or organisation (commercial, academic or other) providing a service used by either the sponsor or the investigator to fulfil…)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Signature  + (Signature A unique mark, symbol or entry executed, adopted or authorised by an individual, in accordance with applicable regulatory requirements and/o…)
• Reference:FRA SI RIPH 2G - Website 16-May-2025 -  + (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 -  + (Soumission à l'ANSM: E-Mail: EC.DM-COS@ansm-sante.fr…)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Source Records  + (Source Records Original documents or data (which includes relevant metadata) or certified copies of the original documents or data, irrespective of …)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 10  + (Specific considerations for vulnerable populations 1. Where the subjects are minors, specific consideration shall be given to the assessment of the…)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor  + (Sponsor An individual, company, institution or organisation that takes responsibility for the initiation, management and arrangement of the financing …)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 3 (6) - (11)  + (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…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 3 (1) - (5)  + (Sponsor of a clinical trial 3.—(1) In these Regulations, subject to the following paragraphs, “sponsor” means, in relation to a clinical trial, the pe…)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor-Investigator  + (Sponsor-Investigator An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the i…)
• Reference:ICH ICH E8 Guideline R1 (2021) 5.1  + (Study Population The population to be studied should be chosen to support the study objectives and is defined through the inclusion and exclusion crit…)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sub-Investigator  + (Sub-Investigator Any individual member of the clinical trial team designated and under the oversight of the investigator to perform significant trial-…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 11  + (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…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 5  + (Submission of an application 1. In order to obtain an authorisation, the sponsor shall submit an application dossier to the intended Member States …)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 16  + (Submission of application In order to obtain an authorisation, the sponsor shall submit an application dossier to the Member States concerned through…)
• Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart B  + (Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research […] § 46.203 Duties of IRBs in connection with re…)
• Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart B  + (Subpart B—Application and Administrative Action § 812.20 Application. (a) Submission. […] (b) Contents […]…)
• Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.10  + (Subpart B—Electronic Records § 11.10 Controls for closed systems. Persons who use closed systems to create, modify, maintain, or transmit electronic r…)
• Reference:USA 21 CFR Part 56 09-Apr-2025 Subpart B  + (Subpart B—Organization and Personnel § 56.106 Registration […] § 56.107 IRB membership. […]…)
• Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart C  + (Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects […] § 46.303 Definitions. […] (c) Pr…)