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EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Section 4 +
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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 2 +
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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 4 +
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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 - Monitoring +
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USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 VI D. +
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EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.4 +
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USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III - IV. +
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USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III B. 3. +
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USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. +
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EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 11 d) +
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EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 Annex 1 +
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