# Protocol Review and Monitoring System

> **NIH NIH P30** · WAYNE STATE UNIVERSITY · 2021 · $102,336

## Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) – ABSTRACT
The Protocol Review and Monitoring System (PRMS) at KCI ensures rigorous review of the scientific merit of
research protocols, prioritization of protocols across the Cancer Center, and monitors progress of all clinical
research. Prior to submission to the PRMC, a first stage review is conducted within each of the Multi-
Disciplinary Teams (MDT), who prioritize protocols within their respective area of expertise and practice. With
respect to prioritization of protocols, the MDT conducts a pre-review of potential protocols for activation to
determine whether they complement the current portfolio of open protocols and whether they should move
forward for submission to the PRMC. The MDT also reviews the protocols for scientific interest and the
likelihood of attaining adequate accrual. This process eliminates redundant reviews by the PRMC and reduces
submission of competing protocols. Although the MDT identifies the prioritization, it is reviewed and confirmed
by the Protocol Review and Monitoring Committee (PRMC). The PRMC fulfills the primary role of the PRMS.
The PRMC is composed of a broad array of complementary expertise with an emphasis on senior investigators
from various disciplines and specialties, as well as representatives from the Biostatistics and Bioinformatics
Core, Pharmacology and Metabolomics Core, the Clinical Trials Office (CTO), the KCI Network, and the
Office of Cancer Health Equity & Community Engagement. The members of the committee represent a
sufficient size and breadth of expertise to conduct a critical and fair scientific review of all clinical research
protocols involving cancer patients at KCI. The PRMC provides internal oversight of the scientific merit of the
cancer trials in addition to assuring that its clinical resources are engaged to ensure the best practices for
scientific endeavors and applications. The function of the PRMC is complementary to that of the IRB, which
focuses on the protection of human subjects. The PRMC is not intended to duplicate or overlap the
responsibilities of the IRB, nor is it intended to perform an auditing or data and safety monitoring function.
Scientific review takes into account the specific rationale, study design, duplication of studies already in
progress elsewhere and at the Cancer Center, adequacy of biostatistical input, and feasibility for completion of
the study within a reasonable time frame. Additionally, the PRMC is responsible for accrual monitoring;
protocols are reviewed regularly to evaluate scientific progress, including accrual rates, to ensure that the
scientific aims of the study are on track for completion in the estimated timeframes indicated at initial
submission.

## Key facts

- **NIH application ID:** 10088985
- **Project number:** 2P30CA022453-39
- **Recipient organization:** WAYNE STATE UNIVERSITY
- **Principal Investigator:** LAWRENCE E FLAHERTY
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $102,336
- **Award type:** 2
- **Project period:** 1997-08-08 → 2025-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10088985

## Citation

> US National Institutes of Health, RePORTER application 10088985, Protocol Review and Monitoring System (2P30CA022453-39). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10088985. Licensed CC0.

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