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- 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 +
- Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Q5.2 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40 Absatz 2 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 33 Absatz 2 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. ; 3. +
- Reference:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 - +
- Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-002 +
- Reference:ICH ICH E8 Guideline R1 (2021) 5.1 +
- Reference:ICH ICH E8 Guideline R1 (2021) 7 +
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 5 +
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-001 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.5 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-001 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. (i) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (c) - (d) +
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 812.36 (c) +
- Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Adherence +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Blinding/Masking +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Randomisation +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.11 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.15 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.3 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 (g) +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.1 +
- Reference:ICH ICH E8 Guideline R1 (2021) 5.6 +
- Reference:ICH ICH E9 Guideline 1998 2.3 +
- Reference:ICH ICH E9 Guideline 1998 2.3.1 +
- Reference:ICH ICH E9 Guideline 1998 Glossary - Double-Dummy +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.2 +
