CORE--CLINICAL TRIAL PROTOCOL REVIEW AND MONITORING SYSTEM

University Of Chicago, Chicago IL

Investigators

Linked publications, trials & patents

Abstract

DESCRIPTION (provided by applicant): The purpose of the Protocol Review and Monitoring System is to review the scientific merit, scientific priorities and scientific progress of cancer related studies that are conducted at the University of Chicago and that use UCCRC resources. In the past year the UCCRC PRMS has been restructured into two committees, the Clinical Trials Review Committee (CTRC) and the Accrual Monitoring Committee (AMC) and a full time Coordinator assigned. The CTRC, a multi-disciplinary committee which meets monthly, has primary responsibility for pre-activation protocol review, that is, evaluation of the scientific merit and rigor, as well as the relative prioritization of a given protocol with respect to other protocols open for that disease site. Protocols are submitted to the CTRC through the PDMO or directly to the PRMS Coordinator who assures inclusion of all necessary components prior to review. A biostatistician in addition to two committee members reviews every protocol. Protocols may be approved, approved with revisions, deferred or disapproved. Although protocols may be submitted simultaneously, CTRC approval is required before IRB approval is granted. Protocols that have undergone prior peer review (e.g., cooperative group protocols, NIH, ACS) are eligible for expedited review, that is, that are not required to be reviewed by the full committee, but rather will be reviewed by the Chair or Co-chair who have the option of bringing them to full committee if there are specific concerns (e.g., design, prioritization). Once a protocol has been approved and activated, the AMC has primary responsibility for the tracking and assessment of protocol progress. More specifically, the AMC, which will convene quarterly, will review patient accrual in relation to projected accrual and accrual rates. Investigators receive notification if their studies are under-accruing. Depending on changes in accrual rates and/or investigator response/explanation over the next 12 months, the AMC will make a recommendation (e.g., continuation without modification, design revisions, study closure) to the Associate Director for Clinical Sciences who will review and have the authority to act on these recommendations. This new PRMS configuration will ensure appropriate resource utilization and study progress.