# Protocol Review and Monitoring System

> **NIH NIH P30** · UNIVERSITY OF CHICAGO · 2020 · $117,056

## Abstract

ABSTRACT
The Protocol Review and Monitoring System (PRMS) serves as the body for scientific review and monitoring of
all cancer-related clinical trials. At the University of Chicago Medicine Comprehensive Cancer Center
(UCCCC), the PRMS consists of two Committees, the Clinical Trials Review Committee (CTRC) and the
Scientific and Accrual Monitoring (SAM) Committee. The overall goal of these Committees is to ensure that all
cancer clinical trials conducted at the UCCCC are of scientific merit, as well as to monitor the progress of these
trials. The CTRC is responsible for the initial protocol review, including scientific rigor (background, statistics),
and feasibility (e.g., in terms of competing studies, and populations seen at University of Chicago Medicine).
The SAM Committee reviews studies annually and assesses overall progress of the study in terms of accrual,
response to any stipulations placed on the protocol at CTRC review, amendments, adequacy of serious
adverse event reporting as well as other items. Over the current grant period, the CTRC conducted full reviews
of 554 protocols, 75 received full approval, 378 received approval with revisions (revisions are reviewed by the
Chair or Co-Chair), 99 were deferred (a new submission and a full review are required), and 2 were
disapproved completely. Over the same time period, the SAM Committee reviewed 943 protocols, with 70
recommended for closure or closed during the SAM review process. Accomplishments over the current grant
period, included enhancement of our informatics infrastructure, adding additional units to the initial review to
ensure technical feasibility (e.g., Human Tissue Resource Center and Pharmacology Core Facility review),
adding a training component for Clinical Fellows and a scoring system for institutional protocols, which
determines whether regulatory management costs are waived. The PRMS is a well-established, efficient and
effective structure for the review of UCCCC clinical protocols. Over the next grant period, we will continue to
refine processes and procedures as needed, including expanding search capacity by categorizing studies
according to various meta-data fields, including molecular mechanisms of action, treatment modality, disease
focus and prior treatments. This then allows for easy filtering and review of similar trials at the CTRC and in the
clinics. In addition, we will move towards electronic submission to the CTRC.

## Key facts

- **NIH application ID:** 9904523
- **Project number:** 5P30CA014599-45
- **Recipient organization:** UNIVERSITY OF CHICAGO
- **Principal Investigator:** HEDY L KINDLER
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $117,056
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9904523

## Citation

> US National Institutes of Health, RePORTER application 9904523, Protocol Review and Monitoring System (5P30CA014599-45). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9904523. Licensed CC0.

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