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- Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart B +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.30 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.42 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart D +
- Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.4 +
- Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.6 +
- Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.8 +
- Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.24 +
- Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.64 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-001 +
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix C-001 +
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix C C.2.3 +
- 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 +
- 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 +
- 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 +
- 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 +
- Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.5 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.57-001 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart G +
- Reference:WMA Declaration of Helsinki 2024 Paragraph 22 +
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B +
- Reference:ICH ICH E6 Guideline R3 (2025) II 7.4 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - protocol +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 2 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Appendix 2 +
- Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 28-29 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - CIP +
- Reference:N.A. SPIRIT 2013 - Chan et al. 2013 - +
- Reference:ICH ICH E8 Guideline R1 (2021) 5. +
