# Protocol Review and Monitoring System

> **NIH NIH P30** · DUKE UNIVERSITY · 2022 · $140,976

## Abstract

ABSTRACT – PROTOCOL REVIEW AND MONITORING SYSTEM 
 Duke Cancer Institute’s Protocol Review and Monitoring System (PRMS) falls within the scope of 
responsibility of the Cancer Protocol Committee (CPC). The CPC is responsible for implementation of the PRMS 
function, including evaluating the scientific merit and progress of all studies that meet the DCI definition of 
“cancer-related”. While the CPC upholds standards in scientific rigor and integrity during the protocol review 
process, it also helps investigators and study teams attain such standards by providing essential resources and 
education. By meeting its scientific oversight responsibilities, the CPC ensures that DCI investigators conduct 
high quality and impactful clinical research that aligns with the DCI’s research priorities and meets the needs of 
the cancer patient community. In addition, the CPC works closely with the clinical Disease Groups and DCI 
CCSG Research Programs in the prioritization of clinical trials for review. 
 The CPC is a scientific peer-review committee comprised of 40 voting members that reflect the 
multidisciplinary clinical research enterprise at the DCI. The CPC membership is selected to ensure diverse 
expertise relevant to cancer clinical research and is composed of clinical investigators, investigational 
pharmacists, biostatisticians, translational PhD scientists, and patient advocates. All cancer-related protocols 
are approved by the CPC prior to activation and approved studies that remain open to enrollment must undergo 
continuing review by the CPC every six months from study activation. Studies reviewed include interventional 
(treatment, preventive, supportive, diagnostic) and non-interventional (ancillary, correlative [tissue-based], 
observational) studies. In addition, amendments to cancer-related studies are prospectively assessed and 
reviewed by the CPC. 
 The CPC approves well-designed studies that hold the potential to positively affect cancer care and has the 
authority to terminate studies that fail to demonstrate meaningful progress or lose relevance due to shifting 
paradigms of cancer research and cancer patient care. During the past project period, CPC reviewed a total of 
1,316 new protocols, 918 annual renewals, and 322 amendments.

## Key facts

- **NIH application ID:** 10323320
- **Project number:** 5P30CA014236-48
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Andrew J Armstrong
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $140,976
- **Award type:** 5
- **Project period:** 1997-01-01 → 2024-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10323320

## Citation

> US National Institutes of Health, RePORTER application 10323320, Protocol Review and Monitoring System (5P30CA014236-48). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10323320. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*