Protocol Review and Monitoring System
The Tisch Cancer Institute (TCI) of Mount Sinai seeks to offer our patients access to cancer clinical trials that are safe and scientifically sound with entry criteria that reflect our patient population. Studies undertaken at Mount Sinai should have a high probability of full accrual, not compete with each other, and have adequate resources to answer the questions being asked. In order to accomplish these goals, the Protocol Review and Monitoring Committee (PRMC) was established in July 2008. As of that date, review of cancer trials by the Institutional Review Board (IRB) of Mount Sinai requires prior approval by the PRMC.
The dual functions of the PRMC are 1) to review the scientific merit and statistical validity of all proposed cancer-related clinical research and prioritize studies to be opened based on their merit, the priorities of the Tisch Cancer Institute, and the availability of resources, and 2) monitor active trials to ensure adequate accrual and scientific progress and to close studies that fail to meet expectations. Auditing for safety and data quality purposed are not a function of the PRMC. The Cancer Clinical Trials Office (CCTO) is responsible for data integrity, and the Data Safety and Monitoring Committee (DSMC) is responsible for the oversight of safe trial conduct.
If you are a Mount Sinai Faculty member, you can access our intranet site to review:
- Meeting and submission deadlines
- Policies and procedures
- Required documents
- Submission applications