Protocol Review and Monitoring System

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 serves as this mechanism throughout the Icahn School of Medicine and the Mount Sinai Health System.

The Protocol Review and Monitoring System includes the following components:

  • Clinical Research Support Unit Finance and Feasibility Review: Determines study feasibility.
  • Disease Focus Groups: These groups review the feasibility and quality of protocols and assign priorities.
  • Protocol Review and Monitoring Committee: Conducts initial review for scientific merit, amendment review for scientific changes, and ongoing review for scientific progress and patient accrual.

The Protocol Review and Monitoring System is a multidisciplinary group whose members have expertise and experience in designing and conducting research studies in medical, surgical, pediatric, and radiation oncology. Members include basic laboratory researchers, cancer prevention/control and population scientists, genetic scientists, biostatisticians, pharmacists, and nurses.

The System ensures that all new protocols support the research mission of The Tisch Cancer Institute through in-depth scientific and statistical review. It reviews data and safety monitoring plans and determines feasibility of the recruitment plan for study completion. The System also monitors active protocols for ongoing scientific progress, closing those that do not meet scientific progress guidelines.

Access our intranet site to review the policies, forms, and meeting schedules.

 

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