Data and Safety Monitoring/NIH Policy

数据和安全监测/NIH 政策

• 批准号: 9002786
• 负责人: Douglas Yee
• 金额: $ 9.58万
• 依托单位: UNIVERSITY OF MINNESOTA
• 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/9002786
• 关键词: Area; Cancer Center; Cancer Center Support Grant; Charge; Charities; Clinical; Clinical Data; Clinical Research; Clinical Services; Clinical Trials; Conduct Clinical Trials; Conflict of Interest; Data; Devices; Ensure; Gifts; Goals; Industry; Investigational New Drug Application; Investigational Therapies; Malignant Neoplasms; Minnesota; Monitor; Monitoring Clinical Trials; Participant; Patients; Policies; Process; Recording of previous events; Regulatory Affairs; Reporting; Research Personnel; Resources; Role; Safety; Services; System; Therapeutic; Time; Translations; United States National Institutes of Health; Universities; University of Minnesota Cancer Center; Update; active method; anticancer research; cost effective; data acquisition; data integrity; data management; follow-up; member; population based; programs; protocol development; success

Clinical Trials Office and Data and Safety Monitoring (DSM) Description The Masonic Cancer Center (MCC) Clinical Trials Office (CTO) was formally established in 2001 with the goal of enhancing MCC members' ability to conduct clinical cancer research by providing centralized and specialized resources and expertise. It assists MCC investigators in developing, activating, and completing scientifically meritorious clinical trials in a high-quality, efficient, cost-effective, centralized manner. At the same time, it ensures the validity and integrity of data in order to fulfill all NCI, federal, and local regulatory requirements. In fiscal year 2012, the CTO opened 42 clinical trials to accrual. As of July 2012, 296 active clinical trials were using CTO services, of which 134 were investigator initiated, 82 were National Cooperative Group trials, and 80 were industry trials. The CTO is currently managing 27 Investigational New Drug Application (IND)/lnvestigational Device Exemption (IDE) trials. A total of 1220 patients (active treatment and follow-up) are currently being followed by the CTO. The CTO focuses on investigator-initiated trials and the translation of basic scientific findings to clinical trials, effectively leveraging MCC resources for the management of our therapeutic translational pipeline. The CTO provides the following major areas of support to MCC investigators: clinical services and data management, regulatory affairs, ClinicalTrials.gov and Clinical Trials Reporting Program registrations and updates, protocol development, clinical trial finance management, project management, system management, clinical trial monitoring and auditing. The MCC Data and Safety Monitoring Plan (DSMP) details the roles and responsibilities of 3 accountable units (PI, MCC, and the University of Minnesota) and the processes that are used by these accountable units to ensure that the highest-quality clinical research is conducted while participant safety is optimized. The current DSMP was approved by the NCI on February 16, 2012. The PI is responsible for all aspects of trial conduct, including clinical trial management, data acquisition, and data and safety monitoring. The MCC has the responsibility of clinical research oversight. The University has oversight for conflict of interest and regulatory standards.

临床试验办公室以及数据与安全监控（DSM）描述 共济会癌症中心（MCC）临床试验办公室（CTO）于2001年正式成立，目的是通过提供集中和专业的资源和专业知识来增强MCC成员进行临床癌症研究的能力。它协助MCC研究人员以高质量，高效，成本效益，集中式的方式开发，激活和完成科学上有功的临床试验。同时，它确保了数据的有效性和完整性，以满足所有NCI，联邦和地方监管要求。在2012财政年度，首席技术官开设了42次临床试验以应计。截至2012年7月，正在使用CTO服务的296次活跃的临床试验，其中134个是研究人员发起的，有82例是国家合作集团试验，80例是行业试验。 CTO目前正在管理27种调查新药应用（IND）/LNVESTIGATITATION设备豁免（IDE）试验。目前，总共有1220名患者（主动治疗和随访）是CTO。 CTO专注于研究人员发起的试验以及将基本科学发现转换为临床试验，从而有效利用MCC资源来管理我们的治疗转化管道。 CTO向MCC调查人员提供以下主要支持领域：临床服务和数据管理，监管事务，临床问题和临床试验报告计划注册和更新，协议开发，临床试验财务管理，项目管理，系统管理，系统管理，临床试验监测和审计。 MCC数据和安全监控计划（DSMP）详细介绍了3个负责任单位（PI，MCC和明尼苏达大学）的角色和职责，以及这些负责任单位使用的过程以确保在优化参与者安全的同时进行最高质量的临床研究。当前的DSMP已于2012年2月16日获得NCI的批准。PI负责试验的各个方面，包括临床试验管理，数据获取以及数据和安全监控。 MCC负责临床研究的监督。该大学对利益冲突和监管标准有监督。