# Procotol Review and Monitoring System

> **NIH NIH P30** · CASE WESTERN RESERVE UNIVERSITY · 2024 · $203,535

## Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM 
Abstract 
The Case Comprehensive Cancer Center (Case CCC) Protocol Review and Monitoring System (PRMS) is 
responsible for scientific evaluation, prioritization, and monitoring of all cancer clinical research studies 
conducted at the Center's consortium institutions. The PRMS is independent of and complements the activities 
of the Institutional Review Boards and Data Safety and Toxicity Committee. The PRMS encompasses activities 
of the Clinical Research Disease Teams and Protocol Review and Monitoring Committee (PRMC), with close 
interaction between these entities. The Case CCC Clinical Research Office (CRO) oversees the PRMS, as the 
central coordinator of clinical trials operations (ex, Clinical Protocol and Data Management), and associated 
committees (PRMC, Data Safety and Toxicity, Minority Accrual, and Clinical Research Operations Committee). 
The CRO is a critical resource for clinical investigators across the Center’s clinical sites, Cleveland Clinic and 
University Hospitals. The Specific Aims are to: 
1) Provide scientific review and prioritization of all applicable cancer-related clinical research protocols 
 across Case CCC consortium institutions 
2) Monitor the progress of ongoing studies to ensure that accrual is sufficient to meet scientific objectives 
The PRMC supports the research programs of the Case CCC by providing scientific review and feedback 
(including feasibility assessment), establishing prioritization, and monitoring progress of and patient accrual in 
active clinical research studies. The PRMC membership is selected to ensure diverse expertise relevant to 
cancer clinical research and is composed of clinical investigators, investigational pharmacists, registered nurses, 
biostatisticians, translational PhD scientists, and patient advocates from consortium member institutions. The 
PRMC operates as a single committee across the Case CCC consortium and reviews all new clinical cancer 
research protocols, including those sponsored by the Center, NCI, other NIH, industry, foundations, or other 
sources. These include interventional (ex, treatment, preventive, supportive, diagnostic), and non-interventional 
(ex, ancillary, correlative [tissue-based], and observational studies). The PRMC has authority to close ongoing 
studies that are not meeting accrual or performance standards and are unlikely to accomplish their scientific 
goals, and a structured process for accrual monitoring and evaluation is followed. All new protocols and protocol 
amendments that include scientific changes, such as revisions in objectives/endpoints, eligibility, 
treatment/dosing, biostatistics, and sample collection, are evaluated by the PRMC. In 2016, there were 588 
active interventional studies at Case CCC monitored by the PRMC. The PRMC reviewed 237 new studies (full 
board review: 183; administrative review: 44; tissue-based: 10). The PRMC also reviewed 330 amendments. 
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## Key facts

- **NIH application ID:** 10831580
- **Project number:** 5P30CA043703-34
- **Recipient organization:** CASE WESTERN RESERVE UNIVERSITY
- **Principal Investigator:** Leland Metheny
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $203,535
- **Award type:** 5
- **Project period:** 1997-08-01 → 2025-06-16

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10831580

## Citation

> US National Institutes of Health, RePORTER application 10831580, Procotol Review and Monitoring System (5P30CA043703-34). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10831580. Licensed CC0.

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