# Protocol Review and Monitoring System

> **NIH NIH P30** · UNIVERSITY OF TX MD ANDERSON CAN CTR · 2020 · $377,585

## Abstract

ABSTRACT: Protocol Review and Monitoring System (PRMS) 
The overall goals of the Protocol Review and Monitoring System (PRMS) are to ensure that all MD Anderson 
human subjects research is of the highest scientific merit and that all approved and/or activated clinical trials 
are completed in a timely manner. The PRMS is supported by 35 staff members (of whom 3 receive a portion 
of support from the CCSG) under the direction of Dr. Aman Buzdar, associate director for clinical research 
administration. Dr. Buzdar oversees all aspects of the PRMS at MD Anderson and reports directly to the 
associate director for clinical and interdisciplinary research, Dr. George Wilding. The PRMS ensures adequate 
internal oversight of the scientific and research aspects of institutional clinical trials through a rigorous review of 
the scientific merit, progress, and priorities of the clinical research protocols conducted by cancer center 
members. The PRMS consists of four Scientific Review Committees (SRC 1–4) and one Psychosocial and 
Behavioral Health Services Research Committee (PBHSRC) that review protocols for scientific merit and 
prioritization. In FY2017, a total of 437 new protocols were submitted to the PRMS (SRC/PBHSRC) peer 
review process, and 382 protocols were reviewed in SRC/PBHSRC meetings, including 342 new interventional 
protocols. The chairs of these committees are also members of the Electronic Protocol Accrual Auditing 
Committee (ePAAC) that selects and monitors all institutional protocols identified as underperforming (e.g., no 
or slow accrual, delayed activations). The ePAAC meets every 6 months and reviews selected protocols, 
including active protocols previously reviewed but requiring a follow-up review at 6 months. A total of 500 
protocol reviews were completed in the last fiscal year (FY2017). An ePAAC subcommittee consisting of 
institutional leadership was recently formed to enhance the quality of the ePAAC review process. This 
subcommittee meets prior to each convened ePAAC meeting to critically review low-performing interventional 
trials that are open for enrollment but have demonstrated consistent challenges in meeting accrual goals post- 
activation (e.g., > 3 consecutive ePAAC reviews) as well as trials that are IRB-approved but have not been 
activated for 6 months or longer. New initiatives include allowing disease-specific programs to select disease- 
specific content experts to conduct the mandatory medical review of SRC-submitted protocols to enhance 
content expertise; documenting types and outcomes (approval/rejection and prioritization) of “local” disease- 
specific protocol reviews; and streamlining protocol activation timelines. In addition, the Office of Clinical 
Research Administration underwent a substantive evaluation of all departments and functions in the spring of 
2018, resulting in a revised organizational structure and greater emphasis on integration and accountability 
across departments to enhance...

## Key facts

- **NIH application ID:** 9997841
- **Project number:** 5P30CA016672-44
- **Recipient organization:** UNIVERSITY OF TX MD ANDERSON CAN CTR
- **Principal Investigator:** Jennifer Keating Litton
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $377,585
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9997841

## Citation

> US National Institutes of Health, RePORTER application 9997841, Protocol Review and Monitoring System (5P30CA016672-44). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9997841. Licensed CC0.

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