Protocol Review and Monitoring System

协议审查和监测系统 项目摘要/摘要 新泽西州罗格斯癌症研究所(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)的工作 协力监督该中心临床研究的所有方面。SRB的重点是 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。以提供 作为肿瘤学主要学科的必要专业知识，SRB由临床、基础和人群组成 科学家、生物统计学家和患者权益倡导者。SRB之前审查了所有与癌症相关的临床方案 机构审查委员会(IRB)审查为评估以下科学价值提供了一个集中的机制 所有癌症临床试验和优先研究，以获得CINJ资源。此外，委员会还审查 CINJ数据和安全监控计划(DSMP)的充分性，并将风险级别分配给干预 研究人员发起的试验(IITs)。 SRB与HROC合作，HROC是一个独立委员会，负责安全审查、应计和 对所有CINJ研究所的研究进展进行监测。所有dsmp活动都属于该委员会的职权范围，并且 在临床方案和数据管理部分进一步描述。虽然HROC是一个独特的 独立委员会，HROC与SRB分享其调查结果和建议，如果这些 被HROC认为可能与试验的科学完整性相关。SRB审查这些内容 调查结果和建议，并有权结束任何不符合应计或 性能标准。重要的是，如果委员会收到不当行为或其他问题的通知， SRB将联系所有适当的当局(IRB、FDA、NCI、资金赞助商等)。视需要而定。 至关重要的是，CINJ拥有一种机制，确保对科学方面的内部监督 该联盟的所有癌症临床试验，作为IRB的补充。

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.