Pages that link to "Glossary:TAG-00071-Pre-nis"
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The following pages link to Glossary:TAG-00071-Pre-nis:
Displaying 13 items.
- Glossary (â links)
- Reference:ICH ICH E21 Concept paper 2023 2. (â links)
- Reference:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 19 (â links)
- Reference:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 18 (â links)
- Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.1.3 (â links)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 33 (â links)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 66 (â links)
- Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart B (â links)
- Reference:ICH ICH E8 Guideline R1 (2021) 4.3.3.1 (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 9.4 (â links)
- Reference:EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005 2.1 (â links)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX III Section 2.1 (â links)
- Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.6.6.1 (â links)
