A defined process to protect the safety of human subjects and maintain the scientific integrity of human subject research and the validity of the data. A DSMP may be a stand-alone document or the section of a protocol that describes the steps to identify physical, social, or psychological occurrences that may result from participation in the research study and explains in detail how such occurrences will be handled and reported. A DSMP describes the timing, tools and/or method(s) for monitoring and evaluation, procedures for treatment or resolution (including circumstances which would result in halting or terminating research). It includes procedures for and timing of reports to oversight bodies, and description of oversight bodies involved with the study (e.g., study team, FDA, IRB, or DSMB). It describes the frequency with which each oversight group reviews the collected information. A study does not need to have a DSMB to have a DSMP. The purpose of a DSMP is to minimize risks for subjects to the extent possible by explicating procedures for monitoring their safety. A DSMP would formalize action items such as:
- methodology for notifying an attending physician of emergent events
- obtaining psychiatric consults for findings of likely suicide
- procedures and education for staff regarding protection of private information
- procedures to follow when subjects experience significant social or emotional upset in response to the research interaction (e.g., a panic attack after an interview and questionnaire)
Note that data collected for safety monitoring (or for research purposes) does not necessarily have to be submitted to IRB as an adverse event report.