# Protocol Review and Monitoring System

> **NIH NIH P30** · EMORY UNIVERSITY · 2024 · $136,354

## Abstract

PROJECT SUMMARY/ABSTRACT
PROTOCOL REVIEW AND MONITORING SYSTEM
The Protocol Review and Monitoring System (PRMS) for Winship Cancer Institute of Emory University
(Winship), is executed by the Protocol Review and Monitoring Committee (PRMC), which aligns clinical
research with research programs and catchment area priorities, and oversees the scientific quality, merit, and
feasibility of clinical trials. The PRMC is responsible for review, prioritization, and monitoring to ensure an
innovative, impactful, and balanced clinical research portfolio that meets the needs of the Winship catchment
area. The PRMC oversees the approval and termination of clinical trials based upon evaluation of scientific
validity, feasibility, and accrual. The PRMC operates independently from the Winship Clinical Trials Office
(CTO) and the DSMC. PRMC reviews are complementary and non-duplicative of IRB reviews. An initial
scientific review is performed by the Winship Treatment Modality Working Groups (TMWG) that meet regularly
to review trials and select studies for inclusion in their portfolios. In 2021, the PRMC reviewed 571 clinical
trials; 40% were new protocols out of which 32% were expedited reviews and 40% institutional and externally-
peer reviewed trials. The PRMC conducts quarterly scientific and accrual progress reviews for active trials.
Enhancements to address new CCSG guidelines and further improve the efficacy of the PRMC since
Winship’s last competitive grant renewal include: (1) risk level determination for all treatment trials; (2)
prioritization of existing trials portfolio and establishment of review criterion of relevance to the catchment
area; (3) annual surveys of Winship members to obtain feedback on PRMC functions and scientific utility; (4)
PRMC membership update to balance representation of clinical specialties, race, ethnicity, and gender; and
(5) enhanced training for TMWG members.

## Key facts

- **NIH application ID:** 10848299
- **Project number:** 5P30CA138292-15
- **Recipient organization:** EMORY UNIVERSITY
- **Principal Investigator:** Ragini Reiney Kudchadkar
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $136,354
- **Award type:** 5
- **Project period:** 2009-04-07 → 2028-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10848299

## Citation

> US National Institutes of Health, RePORTER application 10848299, Protocol Review and Monitoring System (5P30CA138292-15). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10848299. Licensed CC0.

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