# PROTOCOL REVIEW AND MONITORING SYSTEM (Core 013)

> **NIH NIH P30** · WAYNE STATE UNIVERSITY · 2020 · $75,086

## Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM: ABSTRACT 
The Protocol Review and Monitoring System (PRMS) was first implemented in the early 1990s to oversee 
research involving cancer patients at KCI. The main objectives of the PRMS are to: 1) review the scientific 
merit of all cancer research protocols; 2) ensure prioritization of cancer protocols according to KCI's scientific 
priorities; and 3) monitor scientific progress. The Protocol Review and Monitoring Committee (PRMC) 
fulfills the primary role of the PRMS. The committee is composed of a complementary mix of investigators 
from various disciplines and specialties, as well as representatives from the Biostatistics Core, basic science, 
nursing and physician extenders, and administrative support staff from the Clinical Trials Office (CTO). 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. The PRMC evaluates all cancer clinical trials, whether derived and supported 
from NCTN, peer reviewed sources, institutional sources, or from industry. However, the PRMC does not 
duplicate the results of traditional peer review, which includes protocols supported by various NIH mechanisms 
(e.g., R01s, U01s, P01s, U10s and P50s), and clinical research protocols approved by the NCI's Cancer 
Therapy Evaluation Program. These trials are still reviewed for competing studies, feasibility and resource 
allocation. 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:** 9836641
- **Project number:** 5P30CA022453-38
- **Recipient organization:** WAYNE STATE UNIVERSITY
- **Principal Investigator:** Mark Edelstein
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $75,086
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9836641

## Citation

> US National Institutes of Health, RePORTER application 9836641, PROTOCOL REVIEW AND MONITORING SYSTEM (Core 013) (5P30CA022453-38). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9836641. Licensed CC0.

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