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DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 54 +
4.4.0  +
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 55 +
4.4.0  +
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 59 +
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DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63g (3) +
4.4.0  +
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.4 +
4.4.0  +
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.3 +
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AUT BASG - FAQ 11-Feb-2025 Änderung am Personal +
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GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 11 +
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GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 22-23 +
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GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 24 +
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GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 25 +
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USA 21 CFR Part 56 09-Apr-2025 § 56.110 (b) (2) +
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USA 21 CFR Part 312 09-Apr-2025 § 312.30 +
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USA 21 CFR Part 312 09-Apr-2025 § 312.31 +
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USA 21 CFR Part 812 09-Apr-2025 § 812.35 +
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ICH ICH E6 Guideline R3 (2025) GLOSSARY - Audit +
4.5.1  +
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.2 +
4.5.1  +
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WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - audit of a trial +
4.5.1  +
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-002 +
4.5.1  +
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IMDRF IMDRF – Guidelines - - +
4.5.1  +
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