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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.
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- Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) - +
- Reference:INT ISPE - GPP Revision 3 (2015) II. +
- Reference:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) 3 +
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (6) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.25 +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigator’s Brochure (IB) +
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix A +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator’s brochure +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex B +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (5) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.27 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-002 +
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix C-002 +
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.10 +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Contract Research Organisation (CRO) +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Service Provider +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor-Investigator +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3 +
