# Protocol Review and Monitoring System

> **NIH NIH P30** · DANA-FARBER CANCER INST · 2020 · $454,218

## Abstract

Protocol Review and Monitoring System 
Project Summary / Abstract 
Dana-Farber/Harvard Cancer Center (DF/HCC) has a well-developed system for the review, oversight and 
support of cancer-relevant protocols, regardless of the source of support, which are developed and conducted 
at DF/HCC member institutions. The foundations of the centralized infrastructure include: (1) a single Protocol 
Review and Monitoring System (PRMS); (2) a unified data and safety monitoring process (DSMP); (3) a 
common institutional review board system (IRB) for review of cancer-relevant research; and (4) shared access 
to various DF/HCC cores and programs including but not limited to the Biostatistics Core and Early Phase 
Clinical Research Support (EPCRS). Unified clinical trials informatics for the consortium is managed by Clinical 
Protocol and Data Management (CPDM). This consolidated data management functions of the office formerly 
known as the Quality Assurance Office for Clinical Trials with the research informatics function. 
The Protocol Review and Monitoring System (PRMS) focuses on the scientific merit of protocols, prioritization 
and feasibility of trial completion. All proposed cancer-relevant research at member institutions must be 
reviewed and approved by a Scientific Review Committee (SRC) or through expedited administrative scientific 
review, as permitted by the CCSG for peer-reviewed research, and, on an annual basis, reviewed by the 
Scientific Progress Review Committee (SPRC). 
The Office for Human Research Studies (OHRS) manages the operations of the PRMS. Since 2005, the 
PRMS has been under the direction of Michele Russell-Einhorn, JD, who reports to Drew Memmott, the 
Associate Director for Administration of DF/HCC. The PRMS received full approval in 2011.

## Key facts

- **NIH application ID:** 9842690
- **Project number:** 5P30CA006516-55
- **Recipient organization:** DANA-FARBER CANCER INST
- **Principal Investigator:** LAURIE Hollis GLIMCHER
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $454,218
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9842690

## Citation

> US National Institutes of Health, RePORTER application 9842690, Protocol Review and Monitoring System (5P30CA006516-55). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9842690. Licensed CC0.

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