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- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Clinical Trial/Study Report (CSR) +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.13 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 3.17.2 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.10.1.6 +
- Reference:ICH ICH E3 Guideline 1995 - +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - final report +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.16 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex D +
- Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Final report +
- Reference:N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008 - +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 37 Paragraph 4 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 4 – 5 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 6 – 7 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 73 Paragraph 5 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 77 Paragraph 4 – 5 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 77 Paragraph 6 – 7 +
- Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 2. ; 3. +
- Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42b +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-003 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 64 Absatz 3 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63f (4) +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63g (4) +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 67 (6) - NIS +
- Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.2.1 - Start +
- Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.3.7 +
- Reference:GBR HRA - Ending your project 28-Jan-2025 - +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64 (c) - (d) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) (3) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (6) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (7)-002 +
- Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.40 +
- Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.44 +
- Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.54 +
