Data and safety Consultation Committee (DSCC)
The primary purpose of the DSCC is to:
- Aid Sponsor-Investigators conducting IITs in assessing the safety of enrolled participants.
- Evaluate Principal Investigator (PI) oversight.
- Verify protocol and data compliance.
The DSCC operates under the authority of the Associate Dean of Clinical Research and is able to intervene in the conduct of studies as necessary to ensure the safety of research participants and to maintain the highest quality of clinical research data.
The DSCC will work in collaboration with CRSO QA. When CRSO QA identifies relevant findings during monitoring or other study reviews, the DSCC will be notified. The DSCC may then address these findings directly with the study Principal Investigator and/or recommend an action plan to the Associate Dean of Clinical Research.