Protocol Review and Monitoring System

University Of Southern California, Los Angeles CA

Investigators

Linked publications, trials & patents

Abstract

The objectives of the Protocol Review and Monitoring System (PRMS) are to implement a transdisciplinary scientific peer-review system that ensures internal oversight of the scientific quality and progress of clinical trials and optimally engages the institution's resources. The system ensures that clinical research trials at the USC Norris Comprehensive Cancer Center (NCCC) are of the highest scientific quality and integrity by review of the scientific merit, priorities and progress. The specific aims of the PRMS are to: 1) maintain a Clinical Investigation Committee (CIC) with sufficient breadth of expertise to conduct an objective scientific and operational review of all clinical cancer research protocols; 2) facilitate prompt initiation of approved protocols by interfacing with the IRB to ensure compliance with local and federal regulations; 3) ensure and oversee a system of prioritization of clinical research protocols; 4) monitor the scientific progress of clinical research protocols and ensure closure as required by interim analysis and stopping rules; 5) terminate clinical research protocols that fail to meet expectations for scientific progress; 6) review amendments for ongoing clinical research protocols; and 7) monitor compliance as well as gender and minority accrual in the conduct of clinical research protocols. The CIC is assisted by the Quality Assurance and Monitoring Committee (QAMC) in the monitoring of the progress of the studies. The QAMC fulfills multiple functions as detailed in the CISO section of the grant. In regards to PRMS, it provides the essential data regarding accrual and study conduct to the CIC, which allows the latter to perform its progress monitoring functions optimally.