The Tisch Cancer Institute

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Protocol Review and Monitoring System

  1. Clinical Trials

Protocol Review and Monitoring System

The National Cancer Institute (NCI) requires NCI-Designated Cancer Centers involved in clinical research to employ a mechanism for overseeing all scientific aspects of cancer-related protocols. The Tisch Cancer Institute’s Protocol Review and Monitoring System serves as this key mechanism, managing cancer-related clinical research studies across the Mount Sinai Health System.  

Our Protocol Review and Monitoring System is composed of: 

  • Disease Focus Groups, which review feasibility and quality of protocols, and assign priorities. 
  • The Clinical Research Support Unit’s Resource Allocation Evaluation, which determines feasibility. 
  • The Protocol Review and Monitoring Committee, which provides an initial review for scientific merit, amendment review for scientific changes, and continuing review for scientific progress and patient accrual. 

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

All cancer-related clinical research studies at the Mount Sinai Health System are required to be reviewed and approved by the Protocol Review and Monitoring System prior to submission to the Icahn School of Medicine at Mount Sinai’s Institutional Review Board. 

The Tisch Cancer Institute Intranet

Meet the Director

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Keren Osman, MD

Medical Director of Cellular Therapy in the Bone Marrow and Stem Cell Transplantation Program

Keren Osman, MD, is Professor of Medicine, Hematology and Medical Oncology, at the Icahn School of Medicine at Mount Sinai (ISMMS). She is the...

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Review Process

Contact Us

Keri Strauss, MA
Research Program Director

332-227-9935
Email