# Protocol Review and Monitoring System

> **NIH NIH P30** · COLUMBIA UNIVERSITY HEALTH SCIENCES · 2022 · $148,249

## Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM: PROJECT SUMMARY
The Herbert Irving Comprehensive Cancer Center (HICCC) Protocol Review and Monitoring System (PRMS) is
responsible for independent scientific evaluation, prioritization, and monitoring of all cancer clinical research
studies conducted at Columbia University Irving Medical Center (CUIMC). The PRMS is independent of and
complements the activities of the Institutional Review Boards (IRBs) and HICCC Data Safety and Monitoring
Committee (DSMC). The PRMS encompasses activities of the HICCC Disease Based Teams, Feasibility
Committee, and Protocol Review and Monitoring Committee (PRMC). Although independently managed, these
entities maintain close interactions and collaborations. The Specific Aims of the HICCC PRMS are the following:
(1) Provide scientific review and prioritization of all applicable cancer-related clinical research protocols within
the HICCC, (2) Monitor the progress of ongoing studies to ensure that accrual is sufficient to meet scientific
objectives, (3) Determine whether trials should continue or close for lack of scientific progress, and (4) Assess
and implement the recommendations of the Data Safety and Monitoring Committee (DSMC) regarding issues
that may affect the scientific integrity of interventional trials.
The process for review of cancer clinical research studies through the PRMS are as follows:
 Disease Based Teams: Assess new trials for scientific value, fit and prioritization with existing disease-based
 research portfolios
 Feasibility Committee: Review protocol feasibility to determine that adequate resources are in place prior to
 PRMC review
 PRMC: Evaluate interventional protocols for scientific merit, innovation, and statistical soundness so as to
 assess their priority at initial submission. The PRMC also assess the scientific and accrual progress of
 interventional cancer trials at the time of continuing review.
In 2018, the PRMC monitored 381 active interventional studies. The PRMC reviewed 128 new studies (full board
review: 96; expedited review: 32) and 448 amendments.
1

## Key facts

- **NIH application ID:** 10469563
- **Project number:** 5P30CA013696-47
- **Recipient organization:** COLUMBIA UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** ANTONIO TITO FOJO
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $148,249
- **Award type:** 5
- **Project period:** 1997-07-04 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10469563

## Citation

> US National Institutes of Health, RePORTER application 10469563, Protocol Review and Monitoring System (5P30CA013696-47). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10469563. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*