# Protocol Review and Monitoring System

> **NIH NIH P30** · UNIVERSITY OF KANSAS MEDICAL CENTER · 2024 · $62,463

## Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM: ABSTRACT
The Protocol Review and Monitoring System (PRMS) oversees and ensures the scientific merit, appropriate
resourcing, and progress of all cancer-related clinical studies at The University of Kansas Cancer Center
(KUCC) and its consortium partners. PRMS evaluation occurs prior to submission to the Institutional Review
Board (IRB), and does not overlap with its responsibilities. The PRMS has two stages of review: 1) the
Disease Working Groups (DWG; report to the Associate Director (AD) for Clinical Research, Weijing Sun,
MD, FACP; and the Executive Resourcing Committee (ERC; Tara Lin, MD, Chair, reports to AD for Clinical
Research); and 2) the Protocol Review and Monitoring Committee (PRMC; Qamar Khan, MD, Chair, reports
to the Deputy Director, Andrew Godwin, PhD). DWGs set priorities and portfolio needs, ERC evaluates
feasibility and resources, and PRMC performs an independent scientific review. This two-stage process is
formally recorded to maintain prompt activation of high priority studies and aligns with the CCSG guidelines.
The PRMS process is aligned to ensure protocols receive high-quality peer-review and monitoring, and the
research portfolio is consistent with KUCC clinical research priorities and catchment area needs. The 16
DWGs meet monthly for the initial review of scientific merit and available patient resources. The DWGs use a
scoring system to prioritize studies, including disease specific needs. Highest priority is given to funded
investigator-initiated, peer-reviewed 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 Drug
Discovery, Delivery and Experimental Therapeutics program members, members of Cancer Prevention and
Control and Cancer Biology are also part of the DWGs. DWGs are evaluated yearly by the AD for Clinical
Research for proportion of trials that are IIT and/or national, quality, translational nature of interventional trials,
trial accrual, and national meeting presentations and publications. This data is used to further support areas of
need as well as allocate staffing resources to growing and productive teams. The ERC reviews trial feasibility
and resource assessment, protocol resource requirements, and available funding. The CTO sends DWG/ERC
approved studies to the PRMC for scientific review. The PRMC performs independent scientific and
biostatistical reviews, and adequacy of the data safety monitoring. The PRMC also monitors active protocols at
least annually for scientific progress and accruals and terminates studies as appropriate. In 2020, the PRMC
reviewed 287 new studies, 259 were approved and 15 were tabled and nine disapproved. In 2020, the PRMC
reviewed 403 ongoing studies, 49 were placed on probation and 15 were terminated. In August 2020, PRMS
was integrated into the Velos eResearch Clinical Trial Management System resulting in improved t...

## Key facts

- **NIH application ID:** 10906347
- **Project number:** 5P30CA168524-13
- **Recipient organization:** UNIVERSITY OF KANSAS MEDICAL CENTER
- **Principal Investigator:** Qamar J. Khan
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $62,463
- **Award type:** 5
- **Project period:** 2012-07-11 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10906347

## Citation

> US National Institutes of Health, RePORTER application 10906347, Protocol Review and Monitoring System (5P30CA168524-13). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10906347. Licensed CC0.

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