Protocol Review and Monitoring System

PROTOCOL REVIEW AND MONITORING SYSTEM PROJECT SUMMARY/ABSTRACT The Protocol Review and Monitoring System at the Rutgers Cancer Institute of New Jersey (CINJ) consists of the Scientific Review Board (SRB) and the Human Research Oversight Committee (HROC) that work collaboratively to provide oversight of all aspects of clinical research at the Center. The SRB focuses on the scientific merit, scientific priorities and ongoing scientific progress of CINJ clinical research. To provide the necessary expertise in the principal disciplines of oncology, the SRB consists of clinical, basic, and population scientists, biostatisticians, and a patient advocate. The SRB reviews all cancer-related clinical protocols before the Institutional Review Board (IRB) review, provides a centralized mechanism for evaluating scientific merit of all cancer clinical trials and prioritizes studies for access to CINJ resources. In addition, the committee reviews the adequacy of the CINJ Data and Safety Monitoring Plan (DSMP) and assigns level of risk to interventional investigator-initiated trials (IITs). The SRB works with HROC, which is an independent committee responsible for the safety review, accrual and study progress monitoring of all CINJ IITs. All DSMP activities fall under the purview of this committee and are further described in the Clinical Protocol and Data Management section. While the HROC is a distinct independent committee, 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 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 (IRB, FDA, NCI, funding sponsor, etc.) as needed. It is of critical importance that CINJ have a mechanism for ensuring internal oversight of the scientific aspects of all cancer clinical trials of the consortium, complementary to the IRB.