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• Reference:ICH ICH E6 Guideline R3 (2025) Appendix C-001  + (2.1.1)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix C C.2.3  + (2.1.2)
• Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3  + (2.1.2)
• Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.2  + (2.1.2)
• Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.3  + (2.1.2)
• Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 5.1 - 5.2-001  + (2.1.2)
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.5  + (2.1.2)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62  + (2.1.2)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.57-001  + (2.1.2)
• Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart G  + (2.1.2)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 22  + (2.1.3)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B  + (2.1.3)
• Reference:ICH ICH E6 Guideline R3 (2025) II 7.4  + (2.1.3)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - protocol  + (2.1.3)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 2  + (2.1.3)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Appendix 2  + (2.1.3)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 28-29  + (2.1.3)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - CIP  + (2.1.3)
• Reference:N.A. SPIRIT 2013 - Chan et al. 2013 -  + (2.1.3)
• Reference:ICH ICH E8 Guideline R1 (2021) 5.  + (2.1.3)
• Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Glossary  + (2.1.3)
• Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 1.  + (2.1.3)
• Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) -  + (2.1.3)
• Reference:INT ISPE - GPP Revision 3 (2015) II.  + (2.1.3)
• Reference:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) 3  + (2.1.3)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3  + (2.1.3)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (6)  + (2.1.3)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.25  + (2.1.3)

• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigator’s Brochure (IB)  + (2.1.4)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix A  + (2.1.4)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator’s brochure  + (2.1.4)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex B  + (2.1.4)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (5)  + (2.1.4)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.27  + (2.1.4)

• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-002  + (2.1.5)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix C-002  + (2.1.5)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.10  + (2.1.5)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Contract Research Organisation (CRO)  + (2.2.1)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Service Provider  + (2.2.1)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor  + (2.2.1)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor-Investigator  + (2.2.1)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3  + (2.2.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - sponsor  + (2.2.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - contract research organization (CRO)  + (2.2.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.17  + (2.2.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5  + (2.2.1)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9  + (2.2.1)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III 2. ; 7.  + (2.2.1)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 2  + (2.2.1)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 24  + (2.2.1)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b-002  + (2.2.1)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 3 (1) - (5)  + (2.2.1)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 3 (6) - (11)  + (2.2.1)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (e)  + (2.2.1)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (f)  + (2.2.1)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor  + (2.2.1)