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• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 5  + (3.1.4)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 6-001  + (3.1.4)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41  + (3.1.4)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 3-002  + (3.1.4)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 4  + (3.1.4)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 5  + (3.1.4)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (m)  + (3.1.4)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (n)  + (3.1.4)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (o)  + (3.1.4)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (p)  + (3.1.4)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (q)  + (3.1.4)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (r)  + (3.1.4)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (s)  + (3.1.4)
• Reference:USA 21 CFR Part 50 09-Apr-2025 Subpart D  + (3.1.4)
• Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart B  + (3.1.4)
• Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart C  + (3.1.4)
• Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart D  + (3.1.4)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 V.  + (3.1.4)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.4.2  + (3.2.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.3  + (3.2.1)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 44  + (3.2.1)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - recruitment  + (3.2.1)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section K No. 59-60  + (3.2.1)
• 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  + (3.2.1)
• Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Q5.2  + (3.2.1)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40 Absatz 2  + (3.2.1)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 33 Absatz 2  + (3.2.1)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. ; 3.  + (3.2.1)
• Reference:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 -  + (3.2.1)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-002  + (3.2.1)

• Reference:ICH ICH E8 Guideline R1 (2021) 5.1  + (3.2.2)
• Reference:ICH ICH E8 Guideline R1 (2021) 7  + (3.2.2)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 5  + (3.2.2)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-001  + (3.2.2)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.5  + (3.2.2)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-001  + (3.2.2)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. (i)  + (3.2.2)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (c) - (d)  + (3.2.2)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 812.36 (c)  + (3.2.2)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Adherence  + (3.2.2)

• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Blinding/Masking  + (3.3.1)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Randomisation  + (3.3.1)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.11  + (3.3.1)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.15  + (3.3.1)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.3  + (3.3.1)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 (g)  + (3.3.1)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.1  + (3.3.1)
• Reference:ICH ICH E8 Guideline R1 (2021) 5.6  + (3.3.1)
• Reference:ICH ICH E9 Guideline 1998 2.3  + (3.3.1)
• Reference:ICH ICH E9 Guideline 1998 2.3.1  + (3.3.1)
• Reference:ICH ICH E9 Guideline 1998 Glossary - Double-Dummy  + (3.3.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.2  + (3.3.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Introduction  + (3.3.1)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 31  + (3.3.1)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.5  + (3.3.1)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - randomization  + (3.3.1)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.7 (e)  + (3.3.1)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No.17 ; No. 22  + (3.3.2)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section D No. 8  + (3.3.2)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section 2.5 No. 17-22  + (3.3.2)