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• Confirm that your DSMP as outlined in the IRB-approved protocol is followed.
• See this tip sheet that discusses DSMPs and various data and safety monitoring entities.
• Your DSMP may include a data safety monitoring entity for example:
  • Data and Safety Monitoring Board (DSMB)
  • Independent Safety Monitor (ISM)
  • Safety Monitoring Committee (SMC)
• Verify that required information is promptly provided to the data and safety monitoring entity.
• It is your responsibility to notify the data and safety monitoring entity when there are amendments modifications to your protocol that may affect the DSMP.
• Promptly address and respond to the data and safety monitoring entity recommendations. Your responses may include addressing recommendations, or requests for corrective action plans.
• Provide reports from the data safety monitoring entity (DSME) described in your DSMP to the IRB at the time of continuing review or sooner based on the complexity of the report findings and proposed recommendation(s). The DSME makes recommendations whether a study should or should not continue or should be paused based on its review. The NIH IRB is responsible for ensuring that any proposed changes are implemented for overall safety of the protocol and may take action based on recommendations from the DSME. If a DSME report recommends the study be paused or halted, this must be promptly reported to the IRB consistent with Policy 801, Reporting Research Events.

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