Pages that link to "Glossary:TAG-00258-Ser-nfü"
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The following pages link to Glossary:TAG-00258-Ser-nfü:
Displaying 15 items.
- Glossary (← links)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Serious Adverse Event (SAE) (← links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - serious adverse event (← links)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.45 (← links)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 32-34 (← links)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 19 (← links)
- Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.1 (← links)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Life-threatening Adverse event (← links)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - SAE (← links)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 serious adverse event (← links)
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (o) (← 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 (← 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. (← 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. (← links)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.5 (← links)