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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.
List of results
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.43 (c) (5) +
- Reference:WMA Declaration of Helsinki 2024 Paragraph 9 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.1-001 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - escape treatment +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.1 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.7 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 1 (f) +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 4 (j) +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5 (j) +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 7 +
- Reference:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-001 +
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.25 (e) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.60-002 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.100 +
- Reference:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. B. +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Informed Consent +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8 +
- Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.2 +
- Reference:WMA Declaration of Helsinki 2024 Paragraph 25 – 28 +
- Reference:WMA Declaration of Helsinki 2024 Paragraph 31 – 32 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - informed consent +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - witness +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 c) ; e) - g) +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.5 +
- Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 60-61 +
- Reference:WHO WHO - Guidance for best practices for clinical trials 2024 Annex 2 2.5 +
- Reference:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 23 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.2 +
- Reference:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 4. +
