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- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 20 Paragraph 1-3 + (4.4.0)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 20 Paragraph 4-7 + (4.4.0)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 21 + (4.4.0)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 22 + (4.4.0)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 23 Paragraph 1-2 + (4.4.0)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 23 Paragraph 3-6 + (4.4.0)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 24 + (4.4.0)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 75 + (4.4.0)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 71 + (4.4.0)
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40c-002 + (4.4.0)
- Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 8 + (4.4.0)
- Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 9 + (4.4.0)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 40 + (4.4.0)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 41 + (4.4.0)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 42 + (4.4.0)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 54 + (4.4.0)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 55 + (4.4.0)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 59 + (4.4.0)
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63g (3) + (4.4.0)
- Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.4 + (4.4.0)
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.3 + (4.4.0)
- Reference:AUT BASG - FAQ 11-Feb-2025 Änderung am Personal + (4.4.0)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 11 + (4.4.0)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 22-23 + (4.4.0)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 24 + (4.4.0)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 25 + (4.4.0)
- Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.110 (b) (2) + (4.4.0)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.30 + (4.4.0)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.31 + (4.4.0)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.35 + (4.4.0)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Audit + (4.5.1)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.2 + (4.5.1)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - audit of a trial + (4.5.1)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-002 + (4.5.1)
- Reference:IMDRF IMDRF – Guidelines - - + (4.5.1)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex J + (4.5.1)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.11 + (4.5.1)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 17 + (4.5.1)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 + (4.5.1)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 109 Paragraph 1-001 + (4.5.1)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Inspection + (4.5.2)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - inspection + (4.5.2)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-003 + (4.5.2)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11.2 + (4.5.2)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 78 + (4.5.2)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Pragraph 5 + (4.5.2)
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 109 Paragraph 1-002 + (4.5.2)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 5 + (4.5.2)
- Reference:EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012 5 + (4.5.2)
- Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 a) + (4.5.2)
- Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 4.3 + (4.5.2)
- Reference:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-002 + (4.5.2)
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42c + (4.5.2)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 68 + (4.5.2)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 77 + (4.5.2)
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 79 + (4.5.2)
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (l) + (4.5.2)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.58 + (4.5.2)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.68 + (4.5.2)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.145 + (4.5.2)
