A risk-based monitoring approach to source data monitoring and documenting monitoring findings

Clinical trial monitoring is evolving from labor-intensive to targeted approaches. The traditional 100% Source Data Monitoring (SDM) approach fails to prioritize data by significance, diverting attention from critical elements. Despite regulatory guidance on Risk-Based Monitoring (RBM), its widespre...

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Veröffentlicht in:	Contemporary clinical trials 2024-08, Vol.143, p.107581, Article 107581
Hauptverfasser:	Brulotte, Maryse, Alvey, Jessica S., Casper, T. Charles, Cook, Lawrence J., Dwyer, Jamie P., VanBuren, John M.
Format:	Artikel
Sprache:	eng
Schlagworte:	Central data monitoring Clinical Trials as Topic - methods Clinical Trials Data Monitoring Committees - organization & administration Humans Research Design Risk Assessment - methods Risk assessment risk management Risk-based monitoring Source data monitoring Statistical sampling Study monitoring report
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