# Protocol Review and Monitoring System

> **NIH NIH P30** · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · 2021 · $54,216

## Abstract

Project Summary
Protocol Review and Monitoring System (PRMS)
The Perlmutter Cancer Center (PCC) Protocol Review and Monitoring System (PRMS), internally known as
the Protocol Review and Monitoring Committee (PRMC), reviews all cancer-related clinical research under
the jurisdiction of PCC and NYU Langone Health (NYULH). The objectives of the PRMC are to determine
whether a protocol is scientifically and statistically sound, appropriately designed, feasible and not competitive
with other ongoing studies at PCC. The PRMC also determines if protocols are aligned with PCC scientific
priorities and the needs of our catchment area, evaluates whether accrual goals are realistic, and assesses the
likelihood of trial completion. The PRMC has the ultimate authority to approve and prioritize, in an efficient and
timely manner, the activation of cancer-related protocols that have a high level of scientific merit and meet the
scientific priorities of the PCC. The PRMC also decides whether to terminate protocols that do not demonstrate
acceptable progress. Investigator-initiated studies are reviewed for progress at least bi-annually, and other
studies annually. All studies are reviewed more frequently if deemed necessary by the PRMC, due to low
accrual or if protocol amendments significantly change the scientific design or accrual targets of the protocol.
The PRMC is also charged with ensuring that all cancer-related clinical research at NYULH meets appropriate
criteria for inclusion of women, minorities and children. The PRMC is fully integrated into the clinical trials
review and approval systems of NYULH. In this context, it functions in a well-coordinated, expeditious, but
non-overlapping manner with the NYULH IRB, Office of Science and Research (OSR), and various other
NYULH review entities, including Environmental Health and Radiation Safety, Biosafety, and Investigational
Pharmacy. Consistent with the Institutional agreement with the NCI, the NYULH IRB will not grant full approval
to any cancer-related human subjects protocol without receiving documentation of PRMC approval.

## Key facts

- **NIH application ID:** 10124337
- **Project number:** 5P30CA016087-40
- **Recipient organization:** NEW YORK UNIVERSITY SCHOOL OF MEDICINE
- **Principal Investigator:** JAMES SPEYER
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $54,216
- **Award type:** 5
- **Project period:** 1997-12-01 → 2024-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10124337

## Citation

> US National Institutes of Health, RePORTER application 10124337, Protocol Review and Monitoring System (5P30CA016087-40). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10124337. Licensed CC0.

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