Protocol Review and Monitoring System

NIH RePORTER · NIH · P30 · $71,663 · view on reporter.nih.gov ↗

Abstract

PROJECT SUMMARY/ABSTRACT The Protocol Review and Monitoring System (PRMS) of the UC Davis Comprehensive Cancer Center (UCDCCC) provides a mechanism for ensuring internal oversight of the scientific and research aspects of cancer clinical trials and for assuring that the UCDCCC's clinical resources are engaged in the most optimal way. The PRMS is intended to cover clinical research activity meeting the NCI definition of a clinical trial, as defined in the Data and Safety Monitoring Plan (DSMP) within the Clinical Protocol and Data Management of this application. A key element of the PRMS is the Scientific Review Committee (SRC) which provides internal peer-review and approval of new treatment and prevention research trials prior to submission to the Institutional Review Board (IRB), which focuses on the protection of human subjects. SRC provides essential review elements for scientific merit, prioritization, resource allocation and accrual monitoring. This process was improved through the addition of a Protocol Accrual Monitoring Committee (PAMC), a subcommittee of the SRC charged with monitoring accruals and sending reminders to investigators prior to full-board SRC intervention.

Key facts

NIH application ID
9993301
Project number
5P30CA093373-18
Recipient
UNIVERSITY OF CALIFORNIA AT DAVIS
Principal Investigator
HELEN K CHEW
Activity code
P30
Funding institute
NIH
Fiscal year
2020
Award amount
$71,663
Award type
5
Project period
— → —