# Protocol Review and Monitoring System

> **NIH NIH P30** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2021 · $75,569

## Abstract

Abstract: Protocol Review and Monitoring System (PRMS)
Chaired by Leonard Appleman, MD, PhD, Hillman Cancer Center’s (HCC) Protocol Review Committee’s
(PRC) (Protocol Review and Monitoring System (PRC/PRMS) goal is to promote the highest scientific caliber
clinical trials and ensure adequate internal oversight of the scientific aspects of cancer clinical trials with a
focus on scientific merit, priorities, and progress following these specific aims: 1) provide clinical protocol
scientific review before IRB submission, 2) monitor open clinical trials for ongoing scientific merit and
progress, and 3) close trials that fail to meet benchmarks for continued scientific merit and timely accrual.
The priority order of clinical trials for are as follows: external peer-reviewed investigator-initiated trials,
institutional (investigator-initiated) clinical trials, investigator-initiated industry-supported trials, national (ET-
CTN and NCTN) trials, and industry-sponsored trials. PRC/PRMS works in concert with Clinical Protocol and
Data Management (CPDM), and the Data and Safety Monitoring Committee (DSMC) to ensure safe and
efficient conduct of clinical trials at HCC. The PRC/PRMS role is distinct from the DSMC responsibility of
ensuring protocol safety and data quality. The PRC/PRMS also works in conjunction with three other parts of
the clinical trials enterprise: the IRB, the UPMC HCC Biostatistics Facility and the UPMC HCC
Disease/Modality Center (DMC) teams. The PRC/PRMS has three committees (A, B, and C). Committees A
and B alternately review all oncology trials such that one of the Committees meets every 2 weeks to ensure
rapid review of studies and facilitate prompt progression of cancer protocols from the PRC/PRMS to the
responsible IRB. Committee C reviews biobehavioral, cancer epidemiology, cancer prevention and control,
and complementary medicine protocols on an ad hoc basis as required. The PRC/PRMS members are
appointed by the HCC Director Robert Ferris, MD, PhD, in consultation with Antoinette Wozniak, MD, HCC
Associate Director for Clinical Research. The PRC/PRMS committee consists of representative key
academic and clinical faculty from medical oncology, radiation oncology, surgical oncology, pediatric
oncology, and also includes biostatisticians, pharmacists, CPDM staff, clinical fellows and basic cancer
researchers. Pathologists who are members of our DMC teams may be assigned ad hoc as required. The
PRC/PRMS evaluates each protocol for study design, scientific quality, and availability of patient and
financial resources required to complete the proposed trial. PRC/PRMS approval of cancer clinical trials is
required prior to study submission to the Pitt IRB, NCI CIRB, or other accredited IRBs. Once a trial is
opened, the PRC/PRMS reviews its ongoing scientific merit and progress every 6 months. PRC/PRMS has
the authority to request explanations for slow accrual and plans to increase accrual from the study PI, allow
slow accruing trials t...

## Key facts

- **NIH application ID:** 10254118
- **Project number:** 5P30CA047904-33
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** Leonard J. Appleman
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $75,569
- **Award type:** 5
- **Project period:** 1997-09-10 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10254118

## Citation

> US National Institutes of Health, RePORTER application 10254118, Protocol Review and Monitoring System (5P30CA047904-33). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10254118. Licensed CC0.

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