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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 312 09-Apr-2025 § 312.68  + (11:50:13, 16 July 2026)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.145  + (11:50:13, 16 July 2026)
• Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.1-002  + (11:50:13, 16 July 2026)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Serious Adverse Event (SAE)  + (11:50:13, 16 July 2026)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.1  + (11:50:13, 16 July 2026)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a)  + (11:50:13, 16 July 2026)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse event  + (11:50:13, 16 July 2026)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - serious adverse event  + (11:50:13, 16 July 2026)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Oversight  + (11:50:13, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.2  + (11:50:13, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.45  + (11:50:13, 16 July 2026)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 32-34  + (11:50:13, 16 July 2026)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 19  + (11:50:13, 16 July 2026)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 57 – 59  + (11:50:13, 16 July 2026)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 60 – 62  + (11:50:13, 16 July 2026)
• Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.1  + (11:50:13, 16 July 2026)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Adverse event  + (11:50:13, 16 July 2026)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Life-threatening Adverse event  + (11:50:13, 16 July 2026)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - SAE  + (11:50:13, 16 July 2026)
• Reference:USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017) -  + (11:50:13, 16 July 2026)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 adverse event adverse reaction  + (11:50:13, 16 July 2026)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 serious adverse event  + (11:50:13, 16 July 2026)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (m)  + (11:50:13, 16 July 2026)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (o)  + (11:50:13, 16 July 2026)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.1.  + (11:50:13, 16 July 2026)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.28  + (11:50:13, 16 July 2026)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.14.  + (11:50:13, 16 July 2026)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.21.  + (11:50:13, 16 July 2026)

• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.1  + (11:50:14, 16 July 2026)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.2  + (11:50:14, 16 July 2026)
• Reference:ICH ICH E19 Guideline 2022 6  + (11:50:14, 16 July 2026)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Drug Reaction (ADR)  + (11:50:14, 16 July 2026)
• Reference:ICH ICH E2A Guideline 1994 II B. Serious Adverse Event or Adverse Drug Reaction  + (11:50:14, 16 July 2026)
• Reference:ICH ICH E2A Guideline 1994 II B. Serious/Severe  + (11:50:14, 16 July 2026)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse reaction  + (11:50:14, 16 July 2026)

• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Suspected Unexpected Serious Adverse Reaction (SUSAR)  + (11:50:28, 16 July 2026)
• Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.2  + (11:50:28, 16 July 2026)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 8  + (11:50:28, 16 July 2026)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (n)  + (11:50:28, 16 July 2026)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Suspected adverse reaction  + (11:50:28, 16 July 2026)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.2  + (11:50:28, 16 July 2026)
• Reference:ICH ICH E2A Guideline 1994 II A. 3.  + (11:50:28, 16 July 2026)
• Reference:ICH ICH E2A Guideline 1994 III A. 1.  + (11:50:28, 16 July 2026)
• Reference:ICH ICH E2A Guideline 1994 III A. 2.  + (11:50:28, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.51  + (11:50:28, 16 July 2026)
• Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.3  + (11:50:28, 16 July 2026)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 unexpected adverse reaction  + (11:50:28, 16 July 2026)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (p)  + (11:50:28, 16 July 2026)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Unexpected adverse event  + (11:50:28, 16 July 2026)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (s)  + (11:50:28, 16 July 2026)
• Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 III A. ; IV.  + (11:50:28, 16 July 2026)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.32 - 2.1.34  + (11:50:28, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.1  + (11:50:28, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.19  + (11:50:28, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.33  + (11:50:29, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.52  + (11:50:29, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex F  + (11:50:29, 16 July 2026)