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.

方案审查和监测系统 项目概要/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) 合作监督该中心临床研究的各个方面。 SRB 重点关注 CINJ 临床研究的科学价值、科学重点和持续的科学进展。提供 SRB 拥有肿瘤学主要学科的必要专业知识，由临床、基础和人群组成 科学家、生物统计学家和患者倡导者。 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) 审查提供了评估科学价值的集中机制 所有癌症临床试验并优先研究以获得 CINJ 资源。此外，委员会审查 CINJ 数据和安全监测计划 (DSMP) 的充分性，并为干预措施分配风险级别 研究者发起的试验（IIT）。 SRB 与 HROC 合作，HROC 是一个独立委员会，负责安全审查、权责发生制和 所有 CINJ IIT 的研究进度监控。所有 DSMP 活动均属于该委员会的职权范围，并且 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 HROC 认为可能与试验的科学完整性相关。 SRB 审查这些 调查结果和建议，并有权结束任何不符合应计或 绩效标准。重要的是，如果委员会收到不当行为或其他问题的通知， SRB 将根据需要联系所有相关机构（IRB、FDA、NCI、资助机构等）。 至关重要的是，CINJ 拥有确保对科学方面进行内部监督的机制 该联盟的所有癌症临床试验，对 IRB 的补充。