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• Document:GBR The Human Medicines Regulations 2012 01-Jan-2025  + (12:15:25, 16 July 2026)
• Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004  + (12:15:25, 16 July 2026)
• Document:USA 42 CFR Part 11 09-Apr-2025  + (12:15:26, 16 July 2026)
• Document:USA 21 CFR Part 812 09-Apr-2025  + (12:15:26, 16 July 2026)
• Document:USA 21 CFR Part 809 06-May-2024  + (12:15:26, 16 July 2026)
• Document:USA 21 CFR Part 54 09-Apr-2025  + (12:15:26, 16 July 2026)
• Document:USA 45 CFR Part 46 09-Apr-2025  + (12:15:26, 16 July 2026)
• Document:USA 21 CFR Part 56 09-Apr-2025  + (12:15:26, 16 July 2026)
• Document:USA 45 CFR Part 160 09-Apr-2025  + (12:15:26, 16 July 2026)
• Document:USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998  + (12:15:27, 16 July 2026)
• Document:USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018  + (12:15:27, 16 July 2026)
• Document:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013  + (12:15:27, 16 July 2026)
• Document:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023  + (12:15:27, 16 July 2026)
• Document:USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020  + (12:15:27, 16 July 2026)
• Document:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007  + (12:15:27, 16 July 2026)
• Document:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015  + (12:15:27, 16 July 2026)
• Document:USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018  + (12:15:27, 16 July 2026)
• Document:USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017)  + (12:15:27, 16 July 2026)
• Document:USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3  + (12:15:27, 16 July 2026)
• Document:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009  + (12:15:27, 16 July 2026)
• Document:USA NIH - Glossary 27-May-2025  + (12:15:28, 16 July 2026)
• Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024  + (12:15:28, 16 July 2026)
• Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013  + (12:15:28, 16 July 2026)
• Document:USA U.S. Code Title 21 30-Sep-2023  + (12:15:28, 16 July 2026)
• Document:USA FDA Information - Observations and citations 20-Mar-2024  + (12:15:28, 16 July 2026)
• Document:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998  + (12:15:28, 16 July 2026)
• Document:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009  + (12:15:28, 16 July 2026)
• Document:USA Recognized Consensus Standards - ISO 14155 21-Dec-2020  + (12:15:28, 16 July 2026)
• Document:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023  + (12:15:28, 16 July 2026)
• Document:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025  + (12:15:28, 16 July 2026)

• Document:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016  + (12:15:29, 16 July 2026)
• Document:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016  + (12:15:29, 16 July 2026)
• Document:ICH ICH E11 Guideline R1 (2017)  + (12:15:29, 16 July 2026)
• Document:ICH ICH E19 Guideline 2022  + (12:15:29, 16 July 2026)
• Document:ICH ICH E21 Concept paper 2023  + (12:15:29, 16 July 2026)
• Document:ICH ICH E2A Guideline 1994  + (12:15:29, 16 July 2026)
• Document:ICH ICH E2F Guideline 2010  + (12:15:29, 16 July 2026)
• Document:ICH ICH E3 Guideline 1995  + (12:15:29, 16 July 2026)
• Document:ICH ICH E6 Guideline R3 (2025)  + (12:15:29, 16 July 2026)
• Document:ICH ICH E6 Guideline - Annex 2 R3 Annex 2  + (12:15:29, 16 July 2026)

• Document:ICH ICH E7 Guideline 1993  + (12:15:30, 16 July 2026)
• Document:ICH ICH E8 Guideline R1 (2021)  + (12:15:30, 16 July 2026)
• Document:ICH ICH E9 Guideline - Addendum R1 20-Nov-2019  + (12:15:30, 16 July 2026)
• Document:ICH ICH E9 Guideline 1998  + (12:15:30, 16 July 2026)
• Document:IMDRF IMDRF – Guidelines -  + (12:15:30, 16 July 2026)
• Document:INT ISPE - GPP Revision 3 (2015)  + (12:15:30, 16 July 2026)
• Document:INT Nuremberg Code 1947  + (12:15:30, 16 July 2026)
• Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020  + (12:15:30, 16 July 2026)
• Document:N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008  + (12:15:31, 16 July 2026)
• Document:N.A. Article from Mora et al. 2023  + (12:15:31, 16 July 2026)
• Document:N.A. SPIRIT 2013 - Chan et al. 2013  + (12:15:31, 16 July 2026)
• Document:WHO WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Forty-fifth report  + (12:15:31, 16 July 2026)
• Document:WHO WHO - Guidance for best practices for clinical trials 2024  + (12:15:31, 16 July 2026)
• Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995  + (12:15:31, 16 July 2026)
• Document:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005  + (12:15:32, 16 July 2026)
• Document:WMA Declaration of Helsinki 2024  + (12:15:32, 16 July 2026)
• Document:DEU Deutsches Ärzteblatt 45849  + (12:15:32, 16 July 2026)
• Document:EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838  + (12:15:32, 16 July 2026)
• Document:WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026  + (12:15:32, 16 July 2026)
• Document:N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0  + (12:15:32, 16 July 2026)