Cancer Center Data Safety Monitoring Committee Manager - Michelle Uriostigue Preza at email@example.com
Cancer Center Data Safety Monitoring Committee (DSMC), in cooperation with the UIC Office of the Vice Chancellor for Research and the Office for the Protection of Research Subjects, provides for the safety review of selective cancer-related protocols annually. Fifteen individuals from multiple oncology and health care disciplines serve as members of the committee. This diverse composition assures a multidisciplinary approach to safety review.
The DSMC provides review of select University of Illinois Cancer Center (UICC) Oncology Clinical Trials Office managed studies at this time. Investigator-initiated trials (IITs), which are therapeutic interventional studies that are managed by the Cancer Center's Oncology Clinical Trials Office, are reviewed by the DSMC.
A comprehensive safety review is conducted for all new protocols initiated by UICC investigators after IRB approval to determine frequency of review by the DSMC for the above described studies. The DSMC specifically focuses on review of the safety monitoring plan of a protocol to ensure the safety of participants and the validity and integrity of the data.
All serious adverse events experienced by subjects enrolled in trials at the UICC will be reported by the PI per the protocol's safety monitoring plan to the appropriate local and federal authorities, such as the UICC Oncology Clinical Trials Office, the study sponsor, the FDA, and the University of Illinois Office for the Protection of Research Subjects, in accordance with the IRB reporting guidelines.
The DSMC meets at least quarterly. Tentatively 12 meetings are scheduled yearly. The DSMC meeting schedule is listed below. Depending on the needs of the studies under the DSMC's purview, additional ad hoc DSMC meetings may occur.
Click here for the 2015 DSMC Annual Report
For more information about the DSMC, please contact Michelle Uriostigue Preza at firstname.lastname@example.org.