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- Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.4 + (11:49:35, 16 July 2026)
- Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.6 + (11:49:35, 16 July 2026)
- Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.8 + (11:49:35, 16 July 2026)
- Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.24 + (11:49:35, 16 July 2026)
- Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.64 + (11:49:35, 16 July 2026)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-001 + (11:49:35, 16 July 2026)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix C-001 + (11:49:35, 16 July 2026)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix C C.2.3 + (11:49:35, 16 July 2026)
- Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3 + (11:49:35, 16 July 2026)
- Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.2 + (11:49:35, 16 July 2026)
- Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.3 + (11:49:35, 16 July 2026)
- Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 5.1 - 5.2-001 + (11:49:35, 16 July 2026)
- Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.5 + (11:49:35, 16 July 2026)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 + (11:49:35, 16 July 2026)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.57-001 + (11:49:35, 16 July 2026)
- Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart G + (11:49:35, 16 July 2026)
- Reference:WMA Declaration of Helsinki 2024 Paragraph 22 + (11:49:35, 16 July 2026)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B + (11:49:35, 16 July 2026)
- Reference:ICH ICH E6 Guideline R3 (2025) II 7.4 + (11:49:35, 16 July 2026)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - protocol + (11:49:35, 16 July 2026)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 2 + (11:49:35, 16 July 2026)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Appendix 2 + (11:49:35, 16 July 2026)
- Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 28-29 + (11:49:35, 16 July 2026)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - CIP + (11:49:35, 16 July 2026)
- Reference:N.A. SPIRIT 2013 - Chan et al. 2013 - + (11:49:35, 16 July 2026)
- Reference:ICH ICH E8 Guideline R1 (2021) 5. + (11:49:35, 16 July 2026)
- Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Glossary + (11:49:36, 16 July 2026)
- Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 1. + (11:49:36, 16 July 2026)
- Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) - + (11:49:45, 16 July 2026)
- Reference:INT ISPE - GPP Revision 3 (2015) II. + (11:49:45, 16 July 2026)
- Reference:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) 3 + (11:49:45, 16 July 2026)
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 + (11:49:45, 16 July 2026)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (6) + (11:49:45, 16 July 2026)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.25 + (11:49:45, 16 July 2026)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigator’s Brochure (IB) + (11:49:45, 16 July 2026)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix A + (11:49:45, 16 July 2026)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator’s brochure + (11:49:45, 16 July 2026)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex B + (11:49:45, 16 July 2026)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (5) + (11:49:45, 16 July 2026)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.27 + (11:49:45, 16 July 2026)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-002 + (11:49:45, 16 July 2026)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix C-002 + (11:49:45, 16 July 2026)
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.10 + (11:49:45, 16 July 2026)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Contract Research Organisation (CRO) + (11:49:45, 16 July 2026)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Service Provider + (11:49:45, 16 July 2026)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor + (11:49:45, 16 July 2026)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor-Investigator + (11:49:45, 16 July 2026)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3 + (11:49:45, 16 July 2026)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - sponsor + (11:49:46, 16 July 2026)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - contract research organization (CRO) + (11:49:46, 16 July 2026)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.17 + (11:49:46, 16 July 2026)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5 + (11:49:46, 16 July 2026)