# Protocol Review and Monitoring System

> **NIH NIH P30** · UNIVERSITY OF PENNSYLVANIA · 2021 · $386,139

## Abstract

PROJECT SUMMARY – Protocol Review and Monitoring System
The goal of the Abramson Cancer Center (ACC) Protocol Review and Monitoring System (PRMS) is to ensure
scientific merit, priorities, and progress of cancer-related protocols. The ACC PRMS utilizes a first-stage review
of protocols within disease- and discipline-focused Clinical Research Units (CRUs) and second-stage review
by the adult and pediatric scientific protocol committees [Clinical Trials Scientific Review and Monitoring
Committee (CTSRMC) and Pediatric Protocol Review and Monitoring Committee (PPRC)], respectively. The
PPRC is based at Children’s Hospital of Philadelphia (CHOP) and oversees pediatric cancer protocols in
accordance with the same ACC review guidelines and reports to the parent CTSRMC. These functions are
coordinated by Dr. Roger Cohen, the Associate Director for Clinical Research, and Dr. Victoria Sallée, the
Director of the ACC Department of Operations, Compliance and Monitoring (DOCM) – each of whom reports to
and meets regularly with ACC Director Dr. Robert Vonderheide. The CTSRMC and the ACC Director have full
authority to terminate any cancer trial at Penn or CHOP. Both the University of Pennsylvania and the CHOP
Internal Review Boards rely on CTSRMC/PPRC for scientific review of cancer clinical protocols and require
CTSRMC/PPRC approval prior to final IRB approval. CTSRMC/PPRC efforts do not duplicate functions of IRB,
Data Safety Monitoring, or central NCI review bodies. At the time of the last CCSG review, our PRMS was
deemed “Acceptable.” In the current funding period, enhancements to PRMS include further operationalizing
our longstanding “first-stage” protocol review, following the guidance of the new CCSG FOA, as well as
decreasing protocol activation times by 50% (such that the average time-to-activation is now 88 business
days). The latter was accomplished by developing improved tools for data tracking and reporting, implementing
sponsor Master Agreements to minimize budget and contract issues, increasing utilization of CIRB and
commercial IRBs, and instituting reciprocity agreements with other peer PRMS committees. Specific Aims for
PRMS are: (1) Support a first-stage review of clinical protocols at the disease- or discipline-level via our
specialized CRUs; (2) Provide a second-stage scientific, statistical and feasibility review via CTSRMC/PPRC,
which holds sole authority for approval of cancer clinical protocols, and (3) Provide continuing review by
CTSRMC/PPRC of open protocols, including assessment of accrual, safety data, and scientific relevance, with
authority to close trials for deficient accrual, unacceptable safety or scientific deficiencies.

## Key facts

- **NIH application ID:** 10088757
- **Project number:** 2P30CA016520-45
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** Roger B. Cohen
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $386,139
- **Award type:** 2
- **Project period:** 1997-01-15 → 2025-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10088757

## Citation

> US National Institutes of Health, RePORTER application 10088757, Protocol Review and Monitoring System (2P30CA016520-45). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10088757. Licensed CC0.

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