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• Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 Article R1123-20  + (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'infor…)
• Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 Article R1123-20-1  + (Article R1123-20-1 I.-Un système d'information des recherches impliquant la personne humaine permet : 1° Les échanges entre les promoteurs et les co…)
• Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-46  + (Article R1123-46 Pour l'application de la présente section, on entend par : […] 12° Pour les recherches impliquant la personne humaine, fait nouveau :…)
• Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-53  + (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 …)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 18 Paragraph 1-3  + (Assessment of a substantial modification of an aspect covered by Part I of the assessment report 1. The reporting Member State shall assess the app…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 22  + (Assessment of a substantial modification of aspects covered by Parts I and II of the assessment report — Assessment of the aspects covered by Part II …)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 7  + (Assessment report — Aspects covered by Part II 1. Each Member State concerned shall assess, for its own territory, the application with respect to …)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 6  + (Assessment report — Aspects covered by Part I 1. The reporting Member State shall assess the application […] (a) Whether the clinical trial is a l…)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Audit  + (Audit A systematic and independent examination of trial-related activities and records performed by the sponsor, service provider (including contract …)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 19 - 20  + (Authorisation procedure for clinical trials involving medicinal products for gene therapy etc. […] Authorisation procedure for clinical trials involvi…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 18  + (Authorisation procedure for clinical trials involving general medicinal products 18.—(1) This regulation applies to clinical trials involving medicina…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 67  + (Authorised investigational and authorised auxiliary medicinal products 1. Authorised investigational medicinal products and authorised auxiliary me…)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 16  + (B.16 Publication Policy Publication policy, if not addressed in a separate agreement.…)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B. B4  + (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 d…)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-001  + (B.4 Trial Design […] B.4.8 A description of the “stopping rules” or “discontinuation criteria” and “dose adjustment” or “dose interruption” for indivi…)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-002  + (B.4 Trial Design […] B.4.8 A description of the “stopping rules” or “discontinuation criteria” and “dose adjustment” or “dose interruption” for indivi…)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 5  + (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 …)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-001  + (B.6 Discontinuation of Trial Intervention and Participant Withdrawal from Trial The investigator may choose to discontinue the participant from the tr…)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-002  + (B.6 Discontinuation of Trial Intervention and Participant Withdrawal from Trial The investigator may choose to discontinue the participant from the tr…)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 9.4  + (B.9.4 The type and duration of the follow-up of participants after adverse events and other events such as pregnancies.…)
• Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 -  + (Best summarized in this FAQ from the European Commission: https://ec.europa.eu/digital-building-blocks/sites/display/digital/eSignature+FAQ Simple' e…)
• 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…)