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WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.16 +

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EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 37 Paragraph 4 +

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DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42b +

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USA 21 CFR Part 312 09-Apr-2025 § 312.64 (c) - (d) +

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USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) (3) +

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WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026 - +

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N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0 - +

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N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025 - +

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INT ISPE - GPP Revision 3 (2015) - +

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INT ISPE - GPP Revision 3 (2015) II. +

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EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) 3 +

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N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008 - +

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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 4 – 6 +

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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 7 – 9 +

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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 11 +

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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 14 +

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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 45 +

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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 48 +

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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 42 +

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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 58 +

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	This page was last edited on 10 October 2026, at 14:51. Content is available under Creative Commons Attribution unless otherwise noted. Datenschutzrichtlinie Impressum
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