CORE--PROTOCOL REVIEW AND MONITORING SYSTEM

Virginia Commonwealth University, Richmond VA

Investigators

Linked publications & trials

Abstract

All VCU investigational protocols for the treatment of cancer patients are subject to initial and ongoing MCC review for scientific met and scientific progress. The Protocol Review and Monitoring System (PRMS) serves this function. The purposes of the PRMS are: (1) To review the scientific merit and scientific progress of investigational protocols for the treatment of cancer patients according to the scientific standards and priorities of MCC; (2) To establish priorities among protocols potentially competing for patient or other research resources; (3) To advise the Director of the Clinical Protocol and Data Monitoring Shared Resource with regard to the allocation of support for clinical trials. PRMS exercises special oversight of locally-initiated research protocols. Current standards include: (1) All such protocols must have an expert biostatistical investigator; (2) All such protocols must have an Independent Physician Monitor for the review of subject safety issues; (3) All such protocols undergo a Monitoring Committee visit following enrollment of the third research subject and interval visits subsequently. (4) All such protocols undergoing ongoing monitoring for accrual; and (5) Annual or more frequent Progress Reports to PRMS must be signed by both the Principal Investigator and the Study Biostatistician.