# Protocol Review and Monitoring Systems

> **NIH NIH P30** · INDIANA UNIVERSITY INDIANAPOLIS · 2024 · $74,427

## Abstract

ABSTRACT, Protocol Review and Monitoring System (PRMS)
The Scientific Review Committee (SRC) and Protocol Progress Committee (PPC) comprise the Protocol Review
and Monitoring System (PRMS) for the Indiana University Simon Comprehensive Cancer Center (IUSCCC). The
goal of the PRMS is to oversee and provide independent peer review of the scientific merit, feasibility, priority,
and progress of all cancer-related research involving human subjects conducted across IUSCCC. The
oversight of this research is conducted via a rigorous three-stage process conducted by Disease-Oriented
Teams (DOTs), the SRC, and the PPC. The SRC is chaired by Dr. Greg Durm (EDT), and the PPC is chaired
by Dr. Michael Robertson (AM). IUSCCC has 19 DOTs, which are comprised of a disease team leader and
its members. These teams are responsible for the initial review of studies with regards to their feasibility,
research value, and fit within the team portfolio, as well as prioritization of new potential studies and monitoring
of ongoing studies for accrual. The responsibility of the SRC is to rigorously evaluate all potential IUSCCC
cancer-related trials to ensure they are: 1) scientifically sound, 2) effectively and rationally designed with robust
and reproducible biostatistical parameters, 3) appropriately prioritized to avoid competing studies, 4) feasible
for completion based on trial design, accrual goals, and existing resources, 5) assessed for adequacy of data
and safety monitoring plans based on study risk level, and 6) monitored regularly for accrual and scientific
progress. From 2019 to the present, the SRC has reviewed 498 trials from across IUSCCC. The PPC is a
subcommittee of the SRC that is responsible for monitoring accrual and study progress; the PPC makes
recommendations to the SRC for the closure of underperforming trials. Since the beginning of 2019, the PPC
has identified and reviewed 159 under-performing protocols, resulting in closure of 42 and warning letters
issued to 33. IUSCCC's PRMS, inclusive of the SRC and PPC review processes, is a critical component of
IUSCCC's mission to ensure all human subjects research adheres to the highest quality standards and
appropriately utilizes IUSCCC resources.

## Key facts

- **NIH application ID:** 10934646
- **Project number:** 2P30CA082709-25
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** GREG DURM
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $74,427
- **Award type:** 2
- **Project period:** 1999-09-22 → 2029-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10934646

## Citation

> US National Institutes of Health, RePORTER application 10934646, Protocol Review and Monitoring Systems (2P30CA082709-25). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10934646. Licensed CC0.

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