Pages that link to "Template:DocumentData"
From GxPlex
The following pages link to Template:DocumentData:
Displaying 50 items.
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble Preamble (transclusion) (â links)
- Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (8) (transclusion) (â links)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 28 (transclusion) (â links)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 (transclusion) (â links)
- Reference:USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 - (transclusion) (â links)
- Reference:USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018 - (transclusion) (â links)
- Reference:USA Recognized Consensus Standards - ISO 14155 21-Dec-2020 - (transclusion) (â links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - 1.5 Regulatory requirements (transclusion) (â links)
- Reference:DEU MBO - Berufsordnung der Ărzt:innen 11-Jun-2021 § 15 (transclusion) (â links)
- Reference:FRA Infographie - La hiĂ©rarchie des normes 22-Mar-2024 N/A (transclusion) (â links)
- Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 89 (transclusion) (â links)
- Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 55 (transclusion) (â links)
- Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 24 (transclusion) (â links)
- Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 34 (transclusion) (â links)
- Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 37 (transclusion) (â links)
- Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 38 (transclusion) (â links)
- Reference:FRA Guide de lĂ©gistique 07-Feb-2024 - (transclusion) (â links)
- Reference:FRA Infographie - La hiĂ©rarchie des normes 22-Mar-2024 - (transclusion) (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Regulatory Authorities (transclusion) (â links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11 (transclusion) (â links)
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 77 (transclusion) (â links)
- Reference:DEU MPDG - Medizinprodukterecht-DurchfĂŒhrungsgesetz 28-Jun-2022 § 85 (transclusion) (â links)
- Reference:DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024 § 65 (transclusion) (â links)
- Reference:FRA Code de la SantĂ© Publique - Partie lĂ©gislative - 1ere partie, Livre 1er, Titre II 16-May-2025 L5311-1 (transclusion) (â links)
- Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.1-001 (transclusion) (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Institutional Review Board (IRB)/Independent Ethics Committee (IEC) (transclusion) (â links)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 1 (transclusion) (â links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - ethics committee (transclusion) (â links)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Introduction (transclusion) (â links)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.24 (transclusion) (â links)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.26 (transclusion) (â links)
- Reference:WMA Declaration of Helsinki 2024 Paragraph 23 (transclusion) (â links)
- Reference:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 20 (transclusion) (â links)
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41a (transclusion) (â links)
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41b (transclusion) (â links)
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41c (transclusion) (â links)
- Reference:DEU KPBV - Klinische PrĂŒfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 4 (transclusion) (â links)
- Reference:DEU KPBV - Klinische PrĂŒfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 5 (transclusion) (â links)
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 1 1.1 ; 1.3 (transclusion) (â links)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 relevant ethics committee (transclusion) (â links)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 5-6 (transclusion) (â links)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 7-10 (transclusion) (â links)
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (i) (transclusion) (â links)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - IEC (transclusion) (â links)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (f) (transclusion) (â links)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (t) (transclusion) (â links)
- Reference:USA 21 CFR Part 56 09-Apr-2025 - (transclusion) (â links)
- Reference:USA 21 CFR Part 56 09-Apr-2025 Subpart B (transclusion) (â links)
- Reference:USA 21 CFR Part 56 09-Apr-2025 Subpart C (transclusion) (â links)
- Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.107 - § 46.112 (transclusion) (â links)