Participant Management

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Safety Monitoring


  • Safety Monitoring includes provisions for monitoring of data collected for scientific validity and safety of research participants.
  • Monitoring, in general, is the act of overseeing the progress of a clinical study and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP and applicable regulatory requirement(s).


  • For research that involves greater than minimal risk, the investigator should submit a data and safety monitoring (DSM) plan along with the IRB application.
  • The DSM plan should describe the procedures for safety monitoring, reporting of unanticipated problems involving risks to participants or others, descriptions of interim safety reviews and the procedures planned for providing monitoring results to the IRB.
  • DSM may be performed by a researcher, medical monitor, safety monitoring committee, or other means, as appropriate.



  • Data and Safety Monitoring plans should specify:
  • The entity or person(s) who will perform the monitoring, and the independence or affiliation that the entity or person(s) has with the sponsor or investigator;
  • The safety information that will be collected and monitored, including serious adverse events and unanticipated problems;
  • The frequency of review of safety data;
  • The procedure for analysis and interpretation of the data;
  • The procedure for review of scientific literature and data from other sources that may inform the safety or conduct of the study;
  • The conditions that will trigger a suspension or termination of the research (i.e., stopping rules), if applicable;
  • The procedure for reporting to the IRB, including a summary description of what information, or type of information, will be provided.