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List of results
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 22-23 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 24 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 25 +
- Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.110 (b) (2) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.30 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.31 +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.35 +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Audit +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.2 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - audit of a trial +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-002 +
- Reference:IMDRF IMDRF – Guidelines - - +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex J +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.11 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 17 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 109 Paragraph 1-001 +
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Inspection +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - inspection +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-003 +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11.2 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 78 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Pragraph 5 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 109 Paragraph 1-002 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 5 +
- 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 +
- 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) +
- Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 4.3 +
- 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 +
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42c +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 68 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 77 +
