Committees

The UVM Cancer Center has two committees that monitor studies. One, the PRMC, is responsible for the initial scientific review and annual accrual review. The second is responsible for reviewing investigator-initiated cancer studies, the DSMC.

Protocol Review and Monitoring Committee

The membership of the Protocol Review and Monitoring Committee (PRMC) has been designed to provide broad representation from the various oncology subspecialties, including community oncology, and support areas critical to the success of a clinical research enterprise. This broad representation is necessary to provide high quality and thorough protocol review. All members of the PRMC are full voting members. The Co-Directors of the Cancer Center are ex officio members. The committee meets monthly. See a detailed schedule of committee meeting dates.

Data Safety and Monitoring Committee

The DSMC is responsible for monitoring participant safety, the progress of research protocols and the validity and integrity of the data of UVMCC investigator initiated (IIT) cancer-related therapeutic or non-therapeutic intervention trials. The committee does not oversee NCI NCTN, pharmaceutical or institutional trials initiated by an outside institution, but will conduct ad hoc reviews at the request of the IRB or PRMC if concerns are raised regarding external DSMB supervision of participant safety or protocol compliance.

The DSMC operates in collaboration with the Protocol Review and Monitoring Committee (PRMC), which is charged with assigning the risk level of a protocol. Monitoring by the DSMC is based on, and commensurate with, that assignment, with higher-risk protocols requiring more robust monitoring. Data and safety monitoring activities for a study continue by the DSMC until participants have completed the study directed-intervention, are beyond the time point at which study-related adverse events would likely be encountered and data collection is completed.

The DSMC membership is multidisciplinary and includes the following representatives: physician members of the Cancer Center who are active investigators, biostatistician, and pharmacist. The DSMC meets quarterly. See the committee members listed below.

DSMC Forms for PIs

For the Study-Specific Data Safety and Monitoring Plan, required for PRMC submission of an investigator-initiated cancer study, click here.

For the Data Safety and Monitoring Report, due to the DSMC, click here.