# Protocol Review and Monitoring System (Core 018)

> **NIH NIH P30** · OHIO STATE UNIVERSITY · 2020 · $114,105

## Abstract

CORE-018: PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) 
PROJECT SUMMARY / ABSTRACT 
The Protocol Review and Monitoring System [PRMS] of the OSUCCC consists of a Clinical Scientific Review 
Committee [CSRC] that reviews all new cancer-related clinical protocols for scientific merit prior to IRB 
submission and monitors the scientific progress of ongoing studies including accrual rates. The main CSRC is 
organized into two teams (with highly similar composition) that collectively meet twice monthly (each once per 
month), facilitating rapid protocol review. The CSRC consists of 37 members representative of all the 
OSUCCC research programs and includes clinical and basic researchers, biostatisticians, pharmacists, and 
research nurses. Additionally, members with specific expertise in the areas of cancer prevention and control as 
well as pediatrics are convened as CSRC sub-committees to provide focused review of these protocols. At its 
twice monthly meetings, the main CSRC performs full scientific reviews of all cancer-related clinical protocols 
initiated by local investigators or pharmaceutical industry sponsors and acknowledges NIH peer-reviewed 
studies. Each CSRC member is expected to be present at each scheduled meeting, and a majority of the 
voting members scheduled to be at a meeting must be present to attain a quorum for the meeting. Failure to 
achieve a quorum at a meeting precludes any business being conducted. In addition to achieving quorum, 
appropriate reviewer expertise must be present in order for business to be conducted. CSRC approval of a 
protocol is required prior to its review by the OSU Cancer Institutional Review Board. Each protocol is reviewed 
by four CSRC members (a primary reviewer, a secondary reviewer, a biostatistician, and a pharmacist). 
Reviewers follow a written review template that calls for an analysis of the scientific hypothesis and rationale, 
experimental design, patient inclusion and exclusion criteria, treatment plan, statistical plan, pharmacy 
considerations and proper prioritization. As of January 2009, all new research protocols undergo concurrent 
review by the CSRC Logistics Review Committee (LRC), which is a sub-committee of the CSRC. The LRC was 
implemented to facilitate trial activation and confirm proper research prioritization. The LRC does not evaluate 
the scientific aspects of the protocol, but does evaluate the availability of the resources necessary to 
successfully implement and complete the research protocol. The CSRC Executive Committee (EC) provides 
oversight to the CSRC. It is led by the CSRC Chair. The EC consists of eight CSRC members that meet 
monthly to review protocol accrual and scientific progress and ensure that protocol prioritization rules are 
followed. The CSRC EC is responsible for communication with investigators whose clincial trials are not 
meeting their accrual goals and providing support to facilitate accrual. The CSRC adheres to a set of well- 
defined crite...

## Key facts

- **NIH application ID:** 9843879
- **Project number:** 5P30CA016058-44
- **Recipient organization:** OHIO STATE UNIVERSITY
- **Principal Investigator:** DAVID E COHN
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $114,105
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9843879

## Citation

> US National Institutes of Health, RePORTER application 9843879, Protocol Review and Monitoring System (Core 018) (5P30CA016058-44). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/9843879. Licensed CC0.

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