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Glossary:TAG-00140-Ris-nRi

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Glossary > Risk-based monitoring

Risk-based monitoring
Tag-ID TAG-00140-Ris-nRi
English Risk-based monitoring plan
French Plan de monitoring basé sur les risques / Plan de surveillance basé sur les risques
German Risikobasierter Monitoring-Plan / Risikobasierter Überwachungsplan

References

 ScopeDocument partLanguageDocument
EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.4HM4.4ENEU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A.GIV A.ENUSA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. AdherenceGIV A. AdherenceENUSA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. ConductGIV A. ConductENUSA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. VerificationGIV A. VerificationENUSA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013