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), procedures for and timing of reports to oversight bodies, and description of oversight bodies involved with the study (e.g. FDA, IRB, or Data and Safety Monitoring Board). A study does not need to have a Data and Safety Monitoring Board to have a DSMP.