Protocol Review and Monitoring System

Rutgers Biomedical And Health Sciences, Newark NJ

Investigators

Linked publications, trials & patents

Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) PROJECT SUMMARY/ABSTRACT Rutgers Cancer Institute’s PRMS comprises three components: the Disease Specific Groups (DSGs), the Scientific Review Board (SRB), and the Human Research Oversight Committee (HROC). These groups collaborate to provide oversight of all aspects of oncology clinical research at the cancer institute, across the RWJBarnabas Health (RWJBH) system. Since January 2019, RWJBH leadership agreed that all oncology research throughout the system would be conducted in accordance with CCSG processes and under CPDM oversight, as memorialized in a memo executed by Dr. Hochster as Associate Director for Clinical Research and Dr. Libutti as Senior Vice President of Oncology Services. All cancer research throughout the RWJBH system is reviewed by the SRB and under PRMS supervision. Each DSGs is responsible for initial review and prioritization of interventional trials within its portfolio and ongoing scientific relevance of the trial to the disease area. DSG review and written approval are required for any interventional therapeutic trial to have SRB review. The SRB focuses on scientific merit, scientific prioritization for resources, and ongoing scientific progress of the trials; to provide the necessary expertise in the principal disciplines of oncology, it comprises clinical, basic, and population scientists, biostatisticians, community outreach engagement specialists, and patient advocates. By agreement with RBHS, the SRB must review all cancer-related clinical protocols before Institutional Review Board (IRB) review; this provides a centralized mechanism for evaluating the scientific merit of all cancer clinical trials and prioritizes studies for access to cancer institute resources. Community Outreach specialists review each protocol reviewed by SRB to ensure appropriate representation in each interventional trial, making approval and enhancement recommendations. Patient advocates review each protocol for advice on patient acceptability. The SRB reviews the Data and Safety Monitoring Plan (DSMP) and assigns the level of risk to interventional, investigator-initiated trials (IITs). The SRB works with HROC, which functions as an independent Data and Safety Monitoring committee responsible for safety review and accrual/progress monitoring of all IITs. All DSMP activities fall under the purview of HROC, which reports directly to the Center Director and shares its findings and recommendations with the SRB, if these are believed to be potentially relevant to the scientific integrity of the trial. SRB reviews these findings and recommendations and has the sole authority to close any trials that are not meeting accrual or performance standards. If the committee is notified of misconduct or other issues, the SRB will contact all appropriate authorities as needed.