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This page provides a simple browsing interface for finding entities described by a property and a named value. Other available search interfaces include the page property search, and the ask query builder.
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- 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. +
- Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Glossary +
- Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 1. +
- Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) - +
- Reference:INT ISPE - GPP Revision 3 (2015) II. +
- Reference:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) 3 +
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (6) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.25 +
