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RGD: Elements of a Data Monitoring Plan

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Data Monitoring: The regular evaluation of data and documentation collected during a study to ensure both adhere to the approved investigative plan and the validity of data collected (White 2007).

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A data monitoring plan is required for all studies, no matter the risk level.

White S, Field L, Wolf D. Monitoring the Monitors. Applied Clinical Trials. September 2007; p52-60

Type of Document

  • Guidance