The National Cancer Institute (NCI) requires that all NCI Designated Cancer Centers involved in clinical research have a mechanism for assuring adequate internal oversight of the scientific aspects of all cancer-related protocols at the institution. The Tisch Cancer Institute’s Protocol Review and Monitoring System (PRMS) serves as this mechanism and oversees all cancer-related clinical research studies across the Mount Sinai Health System.
The Protocol Review and Monitoring System of the Tisch Cancer Institute is comprised of:
Disease Focus Groups (DFGs): Reviews feasibility and quality of protocols, and assigns priorities
Clinical Research Support Unit (CRSU) Resource Allocation Evaluation (RAE): Determines feasibility
Protocol Review and Monitoring Committee (PRMC): Initial Review for scientific merit, Amendment Review for scientific changes and Continuing review for scientific progress and accrual
The PRMS is responsible for the following:
- Conducting a thorough scientific and statistical review of all new protocols
- Reviewing the appropriateness of Data and Safety Monitoring Plans
- Ensuring the clinical research portfolio supports the research mission of The Tisch Cancer Institute
- Overseeing the appropriate prioritization of protocols
- Monitoring active protocols for ongoing scientific progressand accrual
- Closing protocols that do not meet accrual or scientific progress guidelines
- Evaluates the feasibility of the recruitment plan for study completion
The PRMS has the authority to open protocols that meet the scientific merit and priorities of The Tisch Cancer Institute, and to terminate protocols that do not demonstrate scientific progress. The major goal of the PRMS at the Tisch Cancer Institute is to evaluate the scientific merit and statistical validity of proposed cancer clinical research protocols and to monitor the scientific progress and accrual of active protocols.
Keren Osman, MD
Medical Director of the Cellular Therapy in the Bone
Marrow and Stem Cell Transplantation Program
Marshall Posner, MD
Director, Head/Neck Oncology
All cancer-related clinical research studies at the Mount Sinai Health System are required to be reviewed and approved by the PRMS prior to submission to any Institutional Review Board.
Access our intranet site to review the PRMS Policies, Forms, and Meeting Schedules.