# Protocol Review and Monitoring System

> **NIH NIH P30** · ROSWELL PARK CANCER INSTITUTE CORP · 2024 · $155,427

## Abstract

ABSTRACT – PROTOCOL REVIEW AND MONITORING SYSTEM
The overall goal of the Protocol Review and Monitoring System (PRMS) is to promote rigorous review of the
scientific merit, priorities, and progress of all clinical research, and to ensure that adequate resources are available
at Roswell Park for such research. To address this goal, PRMS employs 3 Specific Aims: 1) Develop and determine
the feasibility and prioritization of protocols; 2) Review protocols for scientific merit, study design, catchment area
needs and relevance to the mission of Roswell Park; and 3) Track and evaluate safety, quality, ongoing scientific
relevance and accrual progress of each study. Operationally, the PRMS manages protocol prioritization, scientific
review, operational implementation and scientific progress of protocols through its committees and charters. PRMS
is comprised of four components, the Clinical Disease Teams (CDTs), the Operational Feasibility Committee, the
Scientific Review Committee, and the Data and Safety Monitoring Committee. CDTs are responsible for
prioritization of disease specific therapeutic interventional trials, with emphasis on prioritizing studies related to
cancers seen in the catchment area and to improve inclusion of minoritized populations, as well as ongoing
scientific relevance of the existing trials. The Operational Feasibility Committee assures adequate resources are
available for each protocol. The Scientific Review Committee (SRC) performs reviews on the scientific merit of
each protocol and determines alignment with the scientific priorities for Roswell Park. In addition, the SRC
evaluates the degree of risk associated with each protocol and monitors progress from recruitment to completion
of clinical research. The SRC has the authority to terminate protocols that do not demonstrate sufficient progress.
Roswell Park continually strives to improve its processes and operations to maximize efficiency and ensure all
clinical research meets high scientific standards. In the previous funding period multiple procedural changes were
made that improved efficiency and refined scientific review. These changes included implementation of disease
site protocol prioritization and portfolio management by CDTs, biannual review of disease site portfolios and closure
of low or slow accruing studies that did not involve rare diseases, and continuing assessment of catchment area
relevance. These procedural changes have been instrumental in achieving a decreased time to SRC approval.
The median time from submission to final SRC approval for all trials decreased from 38 days in 2018 to 19 days in
2022. The number of days from activation date to the first accrual date decreased from 69 days in 2018 to 35 days
in 2022. Clinical Research Services, which is the implementation arm of PRMS, provides Protocol Editors, who
assist investigators in refining their protocols, assuring all required elements are included and improving the overall
quality of protocols s...

## Key facts

- **NIH application ID:** 10848677
- **Project number:** 2P30CA016056-47
- **Recipient organization:** ROSWELL PARK CANCER INSTITUTE CORP
- **Principal Investigator:** Igor Puzanov
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $155,427
- **Award type:** 2
- **Project period:** 1997-06-16 → 2029-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10848677

## Citation

> US National Institutes of Health, RePORTER application 10848677, Protocol Review and Monitoring System (2P30CA016056-47). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10848677. Licensed CC0.

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