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• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 77  + (Bestimmung der zuständigen Bundesoberbehörden und sonstige Bestimmungen § 77 Zuständige Bundesoberbehörde,Verordnungsermächtigung (1) Zuständige Bun…)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Blinding/Masking  + (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…)
• Reference:GBR Medicines and Medical Devices Act 2021 21-Feb-2021 Chapter 2 Article 8  + (CHAPTER 2 International agreements: disclosure of information 8 Disclosure of information in accordance with international agreements (1)This section …)
• Reference:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107m (1)  + (CHAPTER 4 Supervision of post-authorisation safety studies Article 107m 1. This Chapter applies to non-interventional post-authorisation safety st…)
• Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Section 513  + (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 dev…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex VIII  + (CLASSIFICATION RULES…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex VIII  + (CLASSIFICATION RULES…)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X  + (CLINICAL EVALUATION […] 2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member St…)
• Reference:ICH ICH E11 Guideline R1 (2017) -  + (CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION…)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 4  + (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 …)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 5 - 6  + (CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC 5. REPORT BY WHOM. Reportable events have to be re…)
• Reference:ICH ICH E2A Guideline 1994 III B. - III C.  + (CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING III. STANDARDS FOR EXPEDITED REPORTING B. Reporting Time Frames 1.…)
• Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (9)  + (COMMISSION IMPLEMENTING DECISION (EU) 2022/729 of 11 May 2022 – amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for qua…)
• Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (8)  + (COMMISSION IMPLEMENTING DECISION (EU) 2022/729 of 11 May 2022 – amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for qua…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 5  + (CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO AN INCAPACITATED ADULT Conditions 1. The subject’s legal representative has had an interview wit…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 4  + (CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO A MINOR Conditions 1. Subject to paragraph 6, a person with parental responsibility for the mino…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 12.  + (CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS Principles based on International Conference on Harmonisation GCP Guideline [...] 12. In…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 6.  + (CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS Principles based on International Conference on Harmonisation GCP Guideline [...] 6. A t…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 10.  + (CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS Principles based on International Conference on Harmonisation GCP Guideline [...] 10. Al…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2  + (CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS Principles based on International Conference on Harmonisation GCP Guideline…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 7  + (CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS Principles based on International Conference on Harmonisation GCP Guideline 7. The medi…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 16.  + (CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS […] 16. Provision has been made for insurance or indemnity to cover the liability of the…)
• Reference:GBR Data Protection Act 2018 06-Jun-2022 Schedule 10  + (CONDITIONS FOR SENSITIVE PROCESSING UNDER PART 4 Consent to particular processing 1 The data subject has given consent to the processing.Medical purpo…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 3-001  + (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 in…)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Case Report Form (CRF)  + (Case Report Form (CRF) A tool designed to record protocol-required information to be reported by the investigator to the sponsor on each trial partic…)

• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.6  + (Case report forms (CRFs) […]…)

• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Certified Copy  + (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 genera…)
• Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 GLOSSARY OF TERMS  + (Certified Copy: A copy (paper or electronic) of original information that has been verified, as indicated by a dated signature, as an exact copy, havi…)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 9  + (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 th…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 51  + (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…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 47  + (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…)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 6. - 7.-001  + (Clinical Investigation [...] 6. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a c…)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 6. - 7.-002  + (Clinical Investigation [...] 6. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a c…)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Clinical Trial  + (Clinical Trial Any interventional investigation in human participants intended to discover or verify the clinical, pharmacological and/or other pharm…)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Clinical Trial/Study Report (CSR)  + (Clinical Trial/Study Report (CSR) A documented description of a trial of any investigational product conducted in human participants, in which the cl…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I  + (Clinical development stages [...] 1.4 Type of clinical investigation design [...] 1.4.2 Exploratory clinical investigation [...] 1.4.3 Confirmatory c…)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 1. - 4.  + (Clinical investigation 1. In the case of devices intended for clinical investigations, the manufacturer or the authorised representative, established …)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex J  + (Clinical investigation audits…)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - Clinical investigation  + (Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the pu…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - CIP  + (Clinical investigation plan (CIP)…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex D  + (Clinical investigation report D.1 General [...]…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 68  + (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) a…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 64  + (Clinical investigations on incapacitated subjects 1. In the case of incapacitated subjects who have not given, or have not refused to give, informe…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 65  + (Clinical investigations on minors A clinical investigation on minors may be conducted only where, in addition to the conditions set out in Article 62…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 66  + (Clinical investigations on pregnant or breastfeeding women A clinical investigation on pregnant or breastfeeding women may be conducted only where, i…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 74  + (Clinical investigations regarding devices bearing the CE marking 1. Where a clinical investigation is to be conducted to further assess, within the…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 57  + (Clinical trial master file The sponsor and the investigator shall keep a clinical trial master file. The clinical trial master file shall at all time…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 34  + (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 th…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 35 Paragraph 1  + (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) …)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 31 Paragraph 1  + (Clinical trials on incapacitated subjects 1. In the case of incapacitated subjects who have not given, or have not refused to give, informed consen…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 32 Paragraph 1  + (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 th…)