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Human Subjects Research - Data and Safety Monitoring
Last Revised: February 11, 2010

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  1. Does my research need data and safety monitoring?
    45 CFR 46.111(a)(6) states the following requirement for IRB approval of human subjects research:

    "When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects."
  2. Does my research need a Data and Safety Monitoring Plan?
    The NIH Policy for Data and Safety Monitoring states that all NIH funded clinical trials require a Data and Safety Monitoring Plan and that monitoring should be commensurate with risk.

    Most NIH Institutes/Centers have individual Data and Safety Monitoring policies. Click here for the links to I/C-specific policies.
  3. Does my research need a Data and Safety Monitoring Board?
    Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials
    • Data and Safety Monitoring Boards (DSMBs) are specifically required for multi-site clinical trials with interventions that entail risk(s) to participants
    • DSMBs are generally required for Phase III clinical trials
    • A DSMB may be required for Phase I, Phase II or Phase III clinical trials if:
      • The clinical trial is blinded
      • The clinical trial involves high risk intervention(s), or
      • The clinical trial includes vulnerable population(s)

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This page last updated on February 11, 2010
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