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• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 44  + (Page 44)
• Reference:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 Page 6  + (Page 6)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 60-61  + (Page 60-61)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 78  + (Page 78)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 94  + (Page 94)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 17  + (Paragraph 17)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 22  + (Paragraph 22)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 23  + (Paragraph 23)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Amendment approval  + (Paragraph 23 - Amendment approval)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Final report  + (Paragraph 23 - Final report)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Oversight  + (Paragraph 23 - Oversight)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 25 – 28  + (Paragraph 25 – 28)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 29 – 30  + (Paragraph 29 – 30)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 31 – 32  + (Paragraph 31 – 32)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 36  + (Paragraph 36)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 9  + (Paragraph 9)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Part 1 Article 2  + (Part 1 Article 2)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble Preamble  + (Preamble)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble Preamble  + (Preamble)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble Preamble  + (Preamble)
• Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Q1.2  + (Q1.2)
• Reference:USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020 Q15  + (Q15)
• Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Q5.2  + (Q5.2)
• Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-46  + (R1123-46)
• Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-53  + (R1123-53)

• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2  + (Schedule 1 Part 2)

• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 10.  + (Schedule 1 Part 2 10.)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 12.  + (Schedule 1 Part 2 12.)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 16.  + (Schedule 1 Part 2 16.)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 6.  + (Schedule 1 Part 2 6.)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 7  + (Schedule 1 Part 2 7)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 3-001  + (Schedule 1 Part 3)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 3-002  + (Schedule 1 Part 3)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 4  + (Schedule 1 Part 4)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 5  + (Schedule 1 Part 5)
• Reference:GBR Data Protection Act 2018 06-Jun-2022 Schedule 10  + (Schedule 10)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1.  + (Schedule 3 Part 1 1.)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. (i)  + (Schedule 3 Part 1 1. (i))
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. (p)  + (Schedule 3 Part 1 1. (p))
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. ; 3.  + (Schedule 3 Part 1 1. ; 3.)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 5 (5)  + (Schedule 5 (5))
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 7 Part 2 2.  + (Schedule 7 Part 2 2.)
• Reference:AUT BASG - FAQ 11-Feb-2025 Schwarz  + (Schwarz)
• Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 510 (k)  + (Sec 510 (k))
• Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 512 (f)  + (Sec 512 (f))
• Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 737 (8)  + (Sec 737 (8))
• Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Section 513  + (Section 513)
• Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.1  + (Section 7 7.3.1)
• Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.2  + (Section 7 7.3.2)
• Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.3  + (Section 7 7.3.3)
• Reference:USA 21 CFR Part 56 09-Apr-2025 Subpart B  + (Subpart B)