Data and Safety Monitoring Plan (DSMP)

The data and safety monitoring plan describes the system by which appropriate oversight and monitoring is provided to ensure the validity and integrity of data, and participant safety. The method and level of monitoring should correspond to the risk involved in the study.

The principal investigator is responsible for ensuring there is an appropriate DSMP created to submit with the IRB documentation, and that it is followed through the trial.

The DSMP should include:

  • An explanation of the plan
  • Who will perform the monitoring reviews and the frequency
  • Types of data and events to be captured- efficacy, adverse events
  • How events and outcomes of reviews will be reported to the IRB, study sponsor, and other appropriate entities
  • How it will satisfy NIH guidelines and FDA regulations for INDs and IDEs.

Source: Data and Safety Monitoring Plans and Boards. (n.d.). UCSF Human Research Protection Program (HRPP). Retrieved January 8, 2022, from