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EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 Page 6 +
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EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex A A5.3 +
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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 1 +
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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 2 +
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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 3 – 5 +
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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 6 – 7 +
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GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 3-001 +
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