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• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 44  + (11:49:53, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - recruitment  + (11:49:53, 16 July 2026)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section K No. 59-60  + (11:49:53, 16 July 2026)
• 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  + (11:49:54, 16 July 2026)
• Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Q5.2  + (11:49:54, 16 July 2026)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40 Absatz 2  + (11:49:54, 16 July 2026)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 33 Absatz 2  + (11:49:54, 16 July 2026)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. ; 3.  + (11:49:54, 16 July 2026)
• Reference:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 -  + (11:49:54, 16 July 2026)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-002  + (11:49:54, 16 July 2026)
• Reference:ICH ICH E8 Guideline R1 (2021) 5.1  + (11:49:54, 16 July 2026)
• Reference:ICH ICH E8 Guideline R1 (2021) 7  + (11:49:54, 16 July 2026)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 5  + (11:49:54, 16 July 2026)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-001  + (11:49:54, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.5  + (11:49:54, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-001  + (11:49:54, 16 July 2026)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. (i)  + (11:49:54, 16 July 2026)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (c) - (d)  + (11:49:54, 16 July 2026)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 812.36 (c)  + (11:49:54, 16 July 2026)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Adherence  + (11:49:54, 16 July 2026)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Blinding/Masking  + (11:49:54, 16 July 2026)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Randomisation  + (11:49:54, 16 July 2026)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.11  + (11:49:54, 16 July 2026)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.15  + (11:49:54, 16 July 2026)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.3  + (11:49:54, 16 July 2026)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 (g)  + (11:49:54, 16 July 2026)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.1  + (11:49:54, 16 July 2026)
• Reference:ICH ICH E8 Guideline R1 (2021) 5.6  + (11:49:54, 16 July 2026)
• Reference:ICH ICH E9 Guideline 1998 2.3  + (11:49:54, 16 July 2026)
• Reference:ICH ICH E9 Guideline 1998 2.3.1  + (11:49:54, 16 July 2026)
• Reference:ICH ICH E9 Guideline 1998 Glossary - Double-Dummy  + (11:49:54, 16 July 2026)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.2  + (11:49:54, 16 July 2026)

• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Introduction  + (11:49:55, 16 July 2026)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 31  + (11:49:55, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.5  + (11:49:55, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - randomization  + (11:49:55, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.7 (e)  + (11:49:55, 16 July 2026)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No.17 ; No. 22  + (11:49:55, 16 July 2026)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section D No. 8  + (11:49:55, 16 July 2026)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section 2.5 No. 17-22  + (11:49:55, 16 July 2026)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex 5 A5.2  + (11:49:55, 16 July 2026)
• Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Randomisation  + (11:49:55, 16 July 2026)
• Reference:USA 21 CFR Part 314 09-Apr-2025 § 314.126 (4) - (5)  + (11:49:55, 16 July 2026)
• Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.10 (b) (5)  + (11:49:55, 16 July 2026)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Conduct  + (11:49:55, 16 July 2026)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigational Product  + (11:49:55, 16 July 2026)

• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Comparator  + (11:50:04, 16 July 2026)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigational product (synonym: study product)  + (11:50:04, 16 July 2026)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - comparator product  + (11:50:04, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.29  + (11:50:04, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.12  + (11:50:04, 16 July 2026)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.10  + (11:50:04, 16 July 2026)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4.5.3  + (11:50:04, 16 July 2026)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3  + (11:50:04, 16 July 2026)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3.2  + (11:50:04, 16 July 2026)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.6  + (11:50:04, 16 July 2026)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.3  + (11:50:05, 16 July 2026)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.4  + (11:50:05, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-002  + (11:50:05, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.9  + (11:50:05, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-001  + (11:50:05, 16 July 2026)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 51  + (11:50:05, 16 July 2026)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 66  + (11:50:05, 16 July 2026)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 67  + (11:50:05, 16 July 2026)