# Protocol Review and Monitoring System

> **NIH NIH P30** · OREGON HEALTH & SCIENCE UNIVERSITY · 2022 · $201,272

## Abstract

PROJECT SUMMARY: Protocol Review and Monitoring System
Shivaani Kummar, M.D., Associate Director of Clinical and Translational Research
The Knight Cancer Institute (KCI) Protocol Review and Monitoring System (PRMS) supports the development of
a comprehensive and scientifically relevant portfolio of clinical trials. The PRMS ensures that cancer patients
have access to clinical trials that are scientifically sound in design, feasible for timely completion, compliant with
federal guidelines, deserving of priority, and in alignment with the strategic goals of the institute. There are two
distinct stages of scientific review for all clinical trials. The first stage comprises the Clinical Research Disease
Site Group (DSG), and the second stage is the KCI PRMS Committee. Proposed trials undergo an initial review
by the DSG to assess scientific merit, alignment with the KCI and disease site goals, available resources
including relevant patient population, feasibility for completion within the specified timeframe, competing trials,
and fit within a disease-level portfolio. In the second stage of the process, the PRMS reviews for the relevance
of the scientific question, soundness of the design, feasibility to conduct the trial, and ability of the trial to meet
an unmet need within the disease trial portfolio. Eligible protocols undergo a formal scientific progress evaluation
twice yearly to monitor accrual against the target with appropriate corrective actions for protocols that fail to meet
accrual targets. In addition, scientific relevance is re-evaluated for trials open to accrual beyond five years. The
PRMS has full authority to enact the scientific progress evaluation determination. Personnel in the KCI Clinical
Research Quality and Administration group provide administrative support for the PRMS Committee, which acts
independently of the OHSU Institutional Review Board (IRB) and the KCI Data and Safety Monitoring Committee
(DSMC).

## Key facts

- **NIH application ID:** 10411213
- **Project number:** 2P30CA069533-24
- **Recipient organization:** OREGON HEALTH & SCIENCE UNIVERSITY
- **Principal Investigator:** Shivaani Kummar
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $201,272
- **Award type:** 2
- **Project period:** 1997-08-01 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10411213

## Citation

> US National Institutes of Health, RePORTER application 10411213, Protocol Review and Monitoring System (2P30CA069533-24). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10411213. Licensed CC0.

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