Specific DSMC Responsibilities
- Review all internal related or unrelated SAE reports and unanticipated events from studies to assess if there is a change in the risk/benefit ratio that might affect study continuation.
- Submit recommendations for corrective actions to the Principal Investigator.
- Review minutes from data safety monitoring committees external to the UPCI and UPMC CancerCenter (i.e., Phase I, Phase II, Phase II, IV Prevention Trials). Also review scientific reports or other literature that may have an impact on subject safety or continuation of the trial.
- Review other matters that pertain to serious errors or potential misconduct by any of the trial investigators and their research staff. Examples are major protocol violations or breeches in subject or sponsor confidentiality.
- Review any other matters that present safety issues to subjects enrolled on clinical trials not addressed above.