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EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Organisation +
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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5-002 +
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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 7 – 8 +
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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 1.12 +
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USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. A. +
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