Protocol Review and Monitoring System

方案审查和监测系统 项目总结/摘要 新泽西罗格斯癌症研究所（CINJ）的方案审查和监测系统包括 科学审查委员会（SRB）和人类研究监督委员会（HROC）， 协作，以提供在该中心的临床研究的各个方面的监督。工代机构侧重于 CINJ临床研究的科学价值、科学优先事项和正在进行的科学进展。提供 肿瘤学主要学科的必要专业知识，SRB由临床，基础和人口组成 科学家，生物统计学家，还有一个病人的拥护者SRB审查了所有与癌症相关的临床协议， 机构审查委员会（IRB）审查提供了一个集中的机制，用于评估 所有癌症临床试验，并优先研究获得CINJ资源。此外，委员会审查 CINJ数据和安全性监测计划（DSMP）的充分性，并为干预性药物分配风险水平 药物启动试验（IIT）。 SRB与HROC合作，HROC是一个独立的委员会，负责安全审查、应计费用和 所有CINJ IIT的研究进展监测。所有DSMP活动均属于该委员会的职权范围，并且 在临床方案和数据管理章节中进一步描述。虽然HROC是一个独特的 作为一个独立的委员会，人权审查委员会与工代机构分享其调查结果和建议， HROC认为可能与试验的科学完整性相关。SRB审查这些 并有权结束任何未达到应计标准的审判， 业绩标准。重要的是，如果委员会被告知不当行为或其他问题， 供应商审查委员会将联系所有相关机构（IRB、FDA、NCI、资金申办者等）根据需要 至关重要的是，CINJ必须有一个机制，确保对科学方面的内部监督， 联盟的所有癌症临床试验，对IRB进行补充。

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.