Pages that link to "Template:DocumentData"

The following pages link to Template:DocumentData:

Displaying 50 items.

• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 19 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 57 – 59 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 60 – 62 (transclusion) (← links)
• Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.1 (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Adverse event (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Life-threatening Adverse event (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - SAE (transclusion) (← links)
• Reference:USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017) - (transclusion) (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 adverse event adverse reaction (transclusion) (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 serious adverse event (transclusion) (← links)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (m) (transclusion) (← links)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (o) (transclusion) (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.1. (transclusion) (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.28 (transclusion) (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.14. (transclusion) (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.21. (transclusion) (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.1 (transclusion) (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.2 (transclusion) (← links)
• Reference:ICH ICH E19 Guideline 2022 6 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Drug Reaction (ADR) (transclusion) (← links)
• Reference:ICH ICH E2A Guideline 1994 II B. Serious Adverse Event or Adverse Drug Reaction (transclusion) (← links)
• Reference:ICH ICH E2A Guideline 1994 II B. Serious/Severe (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse reaction (transclusion) (← links)
• Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.2 (transclusion) (← links)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 8 (transclusion) (← links)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (n) (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Suspected adverse reaction (transclusion) (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.2 (transclusion) (← links)
• Reference:ICH ICH E2A Guideline 1994 II A. 3. (transclusion) (← links)
• Reference:ICH ICH E2A Guideline 1994 III A. 1. (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Suspected Unexpected Serious Adverse Reaction (SUSAR) (transclusion) (← links)
• Reference:ICH ICH E2A Guideline 1994 III A. 2. (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.51 (transclusion) (← links)
• Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.3 (transclusion) (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 unexpected adverse reaction (transclusion) (← links)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (p) (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Unexpected adverse event (transclusion) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (s) (transclusion) (← links)
• Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 III A. ; IV. (transclusion) (← links)
• 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 (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.1 (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.19 (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.33 (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.52 (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex F (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 64 – 66 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 67–69 (transclusion) (← links)
• Reference:DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021 § 2 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) - (d) (transclusion) (← links)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.4 - 2.5 (transclusion) (← links)