Protocol Review and Monitoring System

PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) PROJECT SUMMARY/ABSTRACT The PRMS at the Rutgers Cancer Institute of New Jersey (CINJ) is composed of three components, the Disease Specific Groups (DSGs), the Scientific Review Board (SRB), and the Human Research Oversight Committee (HROC). These groups work collaboratively to provide oversight of all aspects of oncology clinical research at CINJ, across the RWJBarnabas Health (RWJBH) system. Since January 2019, RWJBH leadership agreed that all oncology research at any of the system hospitals would be conducted in accordance with our CCSG processes and under CPDM oversight, as memorialized in a memo executed by Howard S. Hochster, MD, FACP as Associate Director for Clinical Research and Steven K. Libutti, MD, FACS as Senior Vice President of Oncology Services. All cancer research throughout the RWJBH system is now reviewed by the SRB and under the supervision of the CINJ PRMS. Each of the 13 DSGs is responsible for the initial review and prioritization of interventional trials within its portfolio as well as the ongoing scientific relevance of the trial to the disease area, regardless of the PI or hospital where the PI practices. DSG review and written approval are required for any interventional therapeutic trial in order to be reviewed by the SRB. The SRB focuses on scientific merit, scientific prioritization for CINJ resources, and ongoing scientific progress of the trials. To provide the necessary expertise in the principal disciplines of oncology, the SRB consists of clinical, basic, and population scientists, biostatisticians, community outreach engagement specialists, and patient advocates. By agreement with Rutgers Biomedical Health Sciences (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 CINJ resources. COE community outreach specialists review each protocol reviewed by SRB to ensure appropriate representation by gender, race, ethnicity, and age in each interventional trial, making approval and enhancement recommendations. Patient advocates review each protocol for advice on patient acceptability. The SRB reviews the CINJ 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 CINJ IITs. All DSMP activities fall under the purview of HROC and are further described in the Clinical Protocol and Data Management section. HROC reports directly to the Cancer Center Director. HROC shares its findings and recommendations with the SRB in the event that these are believed by the HROC 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. Importantly, in the event that the committee is notified of misconduct or other issues, the SRB will contact all appropriate authorities (e.g., IRB, FDA, NCI, funding sponsor) as needed.