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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.

List of results

• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (2)  + (6.1.2)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (1) - (3)  + (6.1.2)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (7)-001  + (6.1.2)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4.5.2  + (6.2.0)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 8.3  + (6.2.0)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix C 2  + (6.3.1)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 14.3  + (6.3.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8.3  + (6.3.1)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 58  + (6.3.1)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 3 – 4-002  + (6.3.1)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III 1. ; 3.  + (6.3.1)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 3 – 4-002  + (6.3.1)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 3-002  + (6.3.1)
• Reference:DEU AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung 09-Aug-2019 § 20  + (6.3.1)
• Reference:DEU BGB - Bürgerliches Gesetzbuch 22-Dec-2023 § 630  + (6.3.1)
• Reference:DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 § 10 Absatz 3  + (6.3.1)
• Reference:DEU Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form 01-Mar-2021 -  + (6.3.1)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.6  + (6.3.1)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 8  + (6.3.1)
• Reference:AUT Ärztegesetz 08-Mar-2023 § 51 (3)  + (6.3.1)
• Reference:FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007 2.1  + (6.3.1)
• Reference:FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007 2.1.2  + (6.3.1)
• Reference:GBR NHS: Records Management Code of Practice 07-Aug-2023 -  + (6.3.1)
• Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.6  + (6.3.1)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.57-002  + (6.3.1)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (c)  + (6.3.1)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (d)  + (6.3.1)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (e)  + (6.3.1)
• Reference:USA 45 CFR Part 160 09-Apr-2025 § 164.526  + (6.3.1)
• Reference:USA 45 CFR Part 160 09-Apr-2025 § 164.530  + (6.3.1)

• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Interim Clinical Trial/Study Report  + (6.4.1)
• Reference:ICH ICH E8 Guideline R1 (2021) 6.1.4  + (6.4.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.12  + (6.4.1)
• Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3.1  + (6.4.1)
• Reference:AUT Question - BASG 11-Feb-2025 -  + (6.4.1)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.33  + (6.4.1)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64-002  + (6.4.1)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.36  + (6.4.1)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (3)  + (6.4.1)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (5)  + (6.4.1)

• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Clinical Trial/Study Report (CSR)  + (6.4.2)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.13  + (6.4.2)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 3.17.2  + (6.4.2)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.10.1.6  + (6.4.2)
• Reference:ICH ICH E3 Guideline 1995 -  + (6.4.2)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - final report  + (6.4.2)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.16  + (6.4.2)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex D  + (6.4.2)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Final report  + (6.4.2)
• Reference:N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008 -  + (6.4.2)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 37 Paragraph 4  + (6.4.2)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 4 – 5  + (6.4.2)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 6 – 7  + (6.4.2)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 73 Paragraph 5  + (6.4.2)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 77 Paragraph 4 – 5  + (6.4.2)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 77 Paragraph 6 – 7  + (6.4.2)
• Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 2. ; 3.  + (6.4.2)
• Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3  + (6.4.2)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42b  + (6.4.2)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-003  + (6.4.2)