Data and Safety Monitoring System

数据及安全监控系统

• 批准号: 8321648
• 负责人: Romnee Clark
• 金额: $ 3.12万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8321648
• 关键词: Adverse event; Arbitration; Cancer Center; Cancer Center Support Grant; Clinical Research; Clinical Trials; Communities; Data; Data Quality; Disputes; Ensure; Event; Funding; Goals; Indiana; Industry; Malignant Neoplasms; Monitor; Monitoring Clinical Trials; Oncology Group; Outcome; Policies; Principal Investigator; Procedures; Process; Protocol Compliance; Protocols documentation; Quality Control; Recommendation; Reporting; Research Personnel; Review Committee; Safety; Site; System; Universities; dexamethasone 21-palmitate; patient safety; quality assurance; response

The Data and Safety Monitoring function of the ID Simon Cancer Center is the primary responsibility of the Clinical Trials Monitoring Committee (CTMC). Its function is closely related to the Scientific Review Committee, which evaluates the scientific merit of all cancer-related clinical trials of the Center. The IUSCC Clinical Trials Monitoring Committee (CTMC) is chaired by Dr. Romnee Clark. The primary responsibilities of the CTMC are to assess the adequacy of trial-specific data safety monitoring plans (DMSP's) for each protocol reviewed by the SRC, to review ILJSCC-sponsored studies for patient safety, to ensure protocol and adverse event report compliance, and to conduct internal audits and quality assurance reviews. The Clinical Research Committee (CRC) chaired by Dr. Kathy Miller, Interim Associate Director for Clinical Research, oversees the policies and procedures of the SRC and CTMC, receives monthly reports of the activities of these committees, and arbitrates in the event of disputes.

ID Simon癌症中心的数据和安全监控功能是主要的 临床试验监测委员会（CTMC）的责任。它的功能与 科学审查委员会评估了所有与癌症有关的临床的科学价值 中心试验。 IUSCC临床试验监测委员会（CTMC）由Romnee Clark博士主持。这 CTMC的主要职责是评估特定数据安全的适当性 SRC审查的每个协议的监视计划（DMSP），以审查ILJSCC赞助 研究患者安全，确保协议和不良事件报告的符合性，并进行 内部审计和质量保证评论。 临床研究委员会（CRC）由临时副主任凯西·米勒（Kathy Miller）博士主持 临床研究，监督SRC和CTMC的政策和程序，每月接收 这些委员会活动的报告，并在发生争议时进行仲裁。