Pages that link to "Glossary:TAG-00034-Inv-Bro"
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The following pages link to Glossary:TAG-00034-Inv-Bro:
Displaying 16 items.
- Glossary (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigatorâs Brochure (IB) (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix A (â links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigatorâs brochure (â links)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex B (â links)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (5) (â links)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.45 (â links)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.5.1 (â links)
- Reference:ICH ICH E2A Guideline 1994 II A. 3. (â links)
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (p) (â links)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Unexpected adverse event (â links)
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 16 (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.2 (a) - (b) ; (d) - (f) (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.2 (c) (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix A 3.4 (â links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.6 (â links)
