# Protocol Review and Monitoring System

> **NIH NIH P30** · UNIVERSITY OF KANSAS MEDICAL CENTER · 2021 · $57,269

## Abstract

Protocol Review and Monitoring System – Project Summary
The Protocol Review and Monitoring System (PRMS) oversees and ensures the scientific merit, appropriate
resourcing and progress of all clinical studies at KUCC. KUCC received conditional approval of PRMS at the
2012 NCI site visit and have made multiple personnel and process changes since that time resulting in full
approval in August 2016. The KUCC Clinical Trials Office (CTO) may support the Center's cancer clinical trials
that are approved by the PRMS. The PRMS evaluation occurs prior to submission to the institutional review
board called the Human Subjects Committee (HSC) and does not overlap with HSC responsibilities. The three
components of the PRMS are the Disease Working Groups (DWG; reporting to Associate Director (AD) of
Clinical Research; Carol Fabian, MD, 2016), the Executive Resourcing Committee (ERC; Stephen Williamson,
MD, Chair, 2013, also reporting to AD of Clinical Research), and the Protocol Review and Monitoring
Committee (PRMC; Qamar Khan, MD, Chair 2013, reporting to the Deputy Director). Although each
component has a unique role, these are aligned to ensure protocols are efficiently moved through the system,
receive high-quality peer-review and monitoring, and that the research portfolio is consistent with KUCC clinical
research priorities. The DWGs, which meet monthly, are charged with initial review of clinical trial merit and
feasibility, and with prioritizing by disease-site. Highest priority is given to investigator initiated peer-reviewed
funded trial proposals. DWG co-chairs are appointed by the AD for Clinical Research. Although the DWG
composition is rich in clinicians focused on treatment trials and primarily D3ET members, representatives of
CPS and CCPH are also DWG members. DWGs with significant prevention and survivorship components have
formal liaisons from CPS and CCPH, and this is likely to extend to CB in the future. To further increase
interaction with KUCC programs and translational research, each DWG has one of their meetings per year
replaced by a Clinical Translational Research Meeting focused on their area but chaired by the AD of Clinical
Research with at least 1 basic or behavioral scientist presenting a relevant proposal or ongoing project along
with 1-2 clinical projects. All KUCC members are invited and KUCC program leaders and ADs are expected to
attend. DWGs are evaluated yearly by the AD for proportion of trials that are IIT and/or national, quality and
translational nature of interventional trials, trial accrual, and national meeting presentations and publications.
The ERC reviews protocol resource requirements, available funding, and alignment with KUCC research
programs as defined by the Leadership Council (ADs and Program Leaders); CTO sends ERC approved
studies to the PRMC for Scientific Review. The PRMC performs independent scientific merit and bio-statistical
reviews, including rationale, design, statistical analysis plan, and adeq...

## Key facts

- **NIH application ID:** 10232201
- **Project number:** 5P30CA168524-10
- **Recipient organization:** UNIVERSITY OF KANSAS MEDICAL CENTER
- **Principal Investigator:** Qamar J. Khan
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $57,269
- **Award type:** 5
- **Project period:** 2012-07-11 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10232201

## Citation

> US National Institutes of Health, RePORTER application 10232201, Protocol Review and Monitoring System (5P30CA168524-10). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10232201. Licensed CC0.

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