PROTOCOL REVIEW AND MONITORING SYSTEM

University Of Tx Md Anderson Can Ctr, Houston TX

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY (See instructions): The primary function of the Protocol Review and Monitoring System is to ensure that all human subjects research is of the highest scientific merit and proceeds at an optimal pace. Over the past 5 years, 934 faculty members participating in human subjects research utilized the PRMS, and 273 new interventional protocols were reviewed by the PRMS in the last year. The PRMS is supported by 32 staff members under the direction of Dr. Aman Buzdar, Vice President for Clinical Research Administration. The core function of the PRMS is to provide a mechanism to ensure adequate internal oversight of the scientific and research aspects of all institutional clinical trials through a rigorous review of the scientific merit, progress, and priorities of the clinical research protocols conducted by the faculty. This function is coordinated by the PRMS as a single source of service, support and oversight The PRMS is made up of several subcommittees (described below) that are designated to provide scientific review and approval for new research protocols, as well as to monitor the progress of the ongoing trials. Importantly, the increasingly complex regulatory requirements and oversight activities have resulted in increased institutional staffing commitments and prompted provision of several new or expanded services, as described in greater detail in this application. During the last grant year, the funds used to support the PRMS function were $240,152 (8%) from the Cancer Center Support Grant (CCSG), $110,000 (4%) from IRB fees, and $2,540,868 (88%) from the institution. It is projected that in the next award cycle, the funds used to support the PRMS function will be $249,758 provided by the CCSG (9%), $110,000 from IRB fees (4%), and $2,406,755 (87%) from the institution. The PRMS consists of four Clinical Research Committees (CRCs) and one Psychosocial Behavioral Health Services Research Committee (PBHSRC) that review protocols for scientific merit. The Chairs of these committees are also members of the Electronic Protocol Accrual Auditing Committee (ePAAC) that selects and monitors all institutional protocols that are identified as slow-accruing. Eight hundred and one protocols were reviewed by ePAAC in the last fiscal year, and 115 (14%) were closed or withdrawn. During the last 6 months, substantive changes have been made 1) to make the initial review and prioritization of protocols by the CRC and the disease site programs and departments more rigorous, 2) to reduce the time required for review, and 3) to scrutinize accrual more carefully.