# Protocol Review and Monitoring System

> **NIH NIH P30** · OHIO STATE UNIVERSITY · 2022 · $77,601

## Abstract

PROJECT SUMMARY - PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS)
The Protocol Review and Monitoring System (PRMS) of The Ohio State University Comprehensive Cancer
Center (OSUCCC) consists of a Clinical Scientific Review Committee (CSRC) that reviews all new cancer-related
clinical protocols for scientific merit prior to Cancer Institutional Review Board (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 49 members representative of all five OSUCCC research Programs and
includes clinical and basic researchers, biostatisticians, and pharmacists. Additionally, ad-hoc 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. The 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. A quorum (50% of members) and appropriate reviewer expertise must
be present to conduct CSRC business. CSRC approval of a protocol is required prior to its review by the OSU
Cancer IRB. 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 including analysis of the scientific
hypothesis and rationale, experimental design, patient inclusion and exclusion criteria, treatment plan, statistical
plan, data and safety monitoring plan, pharmacy considerations, accrual of underserved populations and patients
across the lifespan, and proper prioritization. The CSRC Executive Committee (EC) provides oversight to the
CSRC. The EC consists of 11 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 clinical trials are not meeting accrual goals and for providing support to
facilitate accrual. The CSRC adheres to well-defined criteria for accrual monitoring and trial prioritization.
Ongoing studies that do not show adequate accrual or fail to meet accepted standards of quality control based
on formal audits are terminated. In 2019, the CSRC closed 12 trials for low accrual. The average time from
CSRC review to date of approval is 26 days. The EC performs expedited reviews for appropriate studies (e.g.,
retrospective studies requesting access to medical records). In the last grant period, 1,070 new interventional
protocols were reviewed by the CSRC with the following dispositions: 297 (28%) were approved as written, 345
(32%) were approved with stipulations, 76 (7%) were deferred, 297 (28%) were administratively acknowledged
...

## Key facts

- **NIH application ID:** 10333288
- **Project number:** 5P30CA016058-46
- **Recipient organization:** OHIO STATE UNIVERSITY
- **Principal Investigator:** Bhuvaneswari Ramaswamy
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $77,601
- **Award type:** 5
- **Project period:** 1997-09-12 → 2025-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10333288

## Citation

> US National Institutes of Health, RePORTER application 10333288, Protocol Review and Monitoring System (5P30CA016058-46). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10333288. Licensed CC0.

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