Protocol Review and Monitoring System

NIH RePORTER · NIH · P30 · $151,706 · view on reporter.nih.gov ↗

Abstract

ABSTRACT: PROTOCOL REVIEW AND MONITORING SYSTEM The UNC Lineberger Comprehensive Cancer Center’s Protocol Review and Monitoring System (PRMS) facilitates internal oversight of the scientific aspects of all cancer clinical trials at the University of North Carolina focusing on the scientific merit, priorities, and progress of clinical protocol research. The system is a multi-step process with preliminary review by Protocol Office Disease teams (PODs) and the Resource and Feasibility Team (RAFT) followed by formal scientific review by the Protocol Review Committee (PRC). The PRC is chaired by Autumn McRee, MD, and meets bi-monthly to review every cancer-related clinical protocol before it is submitted to The Office of Human Research Ethics’ Institutional Review Board (IRB). The PRC’s primary function is to ensure the scientific quality of proposed studies. As described in Clinical Protocol and Data Management (CPDM), PODs and RAFT review protocols for feasibility, quality, and priority before they are submitted to the PRC. The PRC monitors study accrual and has the authority to close under- performing trials. During 2019, the PRC reviewed 392 protocols: 156 new studies and 236 active trials for renewal and monitoring. This represents an 8% increase over the PRMS activity at the time of our last renewal and reflects both our growth and dedication to an effective PRMS process.

Key facts

NIH application ID
10089824
Project number
2P30CA016086-45
Recipient
UNIV OF NORTH CAROLINA CHAPEL HILL
Principal Investigator
AUTUMN J MCREE
Activity code
P30
Funding institute
NIH
Fiscal year
2021
Award amount
$151,706
Award type
2
Project period
1997-06-01 → 2025-11-30