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- Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3.1 +
- Reference:N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008 - +
- Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Final report +
- Reference:AUT Question - BASG 11-Feb-2025 - +
- Reference:ICH ICH E8 Guideline R1 (2021) 6.1.4 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - final report +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.33 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 3.17.2 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (d) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64-002 +
- Reference:AUT Ärztegesetz 08-Mar-2023 § 51 (3) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.57-002 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.12 +
- Reference:FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007 2.1.2 +
- Reference:USA 45 CFR Part 160 09-Apr-2025 § 164.530 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.13 +
- Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.6 +
- Reference:USA 45 CFR Part 160 09-Apr-2025 § 164.526 +
- Reference:ICH ICH E3 Guideline 1995 - +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex D +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (3) +
- Reference:FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007 2.1 +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Interim Clinical Trial/Study Report +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.10.1.6 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.16 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.36 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (5) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (c) +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Clinical Trial/Study Report (CSR) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (e) +
- Reference:GBR NHS: Records Management Code of Practice 07-Aug-2023 - +