Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10580702
• 负责人: Salma Jabbour
• 金额: $ 7.92万
• 依托单位: RUTGERS BIOMEDICAL AND HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-03-01 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10580702
• 关键词: Address; Adverse event; Advocate; Authorization documentation; Cancer Center Support Grant; Cancer Institute of New Jersey; Catchment Area; Clinical; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Data; Discipline; Ensure; Event; Funding; Guidelines; Human; Institution; Institutional Review Boards; Intervention; Laws; Malignant Neoplasms; Mission; Monitor; Notification; Oncology; Outcome; Patients; Performance; Population; Protocols documentation; Recommendation; Research; Research Personnel; Resource Allocation; Resources; Review Committee; Risk; Safety; Science; Scientist; System; United States National Institutes of Health; Work; authority; cancer clinical trial; data management; design; investigator-initiated trial; patient population; sound; tumor progression

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.

协议审查和监视系统 项目摘要/摘要 新泽西州罗格斯癌症研究所（CINJ）的协议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）工作 协作以监督该中心临床研究的各个方面。 SRB专注于 CINJ临床研究的科学功绩，科学重点和持续的科学进步。提供 在肿瘤学的主要学科中，SRB的必要专业知识包括临床，基础和人群 科学家，生物统计学家和患者拥护者。 SRB审查了所有与癌症相关的临床方案 机构审查委员会（IRB）审查提供了一种集中的机制，用于评估科学优点 所有癌症临床试验，并确定研究CINJ资源的研究。此外，委员会审查 CINJ数据和安全监控计划（DSMP）的充分性，并将风险级别分配给介入 研究人员发动的试验（IIT）。 SRB与HROC合作，该委员会是负责安全审查的独立委员会 研究所有CINJ IIT的进度监控。所有DSMP活动都属于该委员会的权限，并且是 在临床方案和数据管理部分中进一步描述。而HROC是独特的 独立委员会，HROC与SRB分享了其发现和建议，如果这些 HROC认为可能与试验的科学完整性有关。 SRB回顾了这些 调查结果和建议，并有权关闭任何未符合应计或的审判 性能标准。重要的是，如果将委员会通知委员会不当行为或其他问题， SRB将根据需要与所有适当的当局（IRB，FDA，NCI，资助赞助商等）联系。 CINJ具有确保内部监督科学方面的机制，这一点至关重要 所有财团的癌症临床试验，与IRB互补。