Data & Safety Monitoring

数据

基本信息

批准号：
9282721
负责人：
KAREN E KNUDSEN
金额：
$ 21.89万
依托单位：
THOMAS JEFFERSON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-06-01 至 2018-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9282721
关键词：
Address Adverse event Amendment Behavioral Research Biomedical Research Cancer Center Charge Clinical Clinical Cancer Center Clinical Research Clinical Trials Clinical Trials Data Monitoring Committees Communication Communities Data Devices Ensure Faculty Hour Institutes Institutional Review Boards Instruction Kimmel Cancer Center at the Thomas Jefferson University Malignant Neoplasms Modification Monitor Monitoring Clinical Trials Nature Notification Office Management Participant Pharmaceutical Preparations Pharmacy facility Protocols documentation Reporting Research Research Activity Research Personnel Review Committee Safety Schedule Social Welfare Specific qualifier value Suspensions Teleconferences Therapeutic Time Translational Research Universities University Hospitals anticancer research authority base cancer research center director clinical investigation data integrity falls human subject human subject protection meetings member multidisciplinary patient safety programs

项目摘要

DATA AND SAFETY MONITORING The Data and Safety Monitoring Plan (DSMP) of the Kimmel Cancer Center (KCC) provides for the oversight and monitoring of clinical trials to ensure the: 1. Safety of patients; and 2. Validity and integrity of the data collected on these trials. Responsibility for data and safety monitoring at Thomas Jefferson University (TJU) resides in: 1. The Clinical Cancer Research Review Committee (CCRRC) which oversees the scientific review of all new and ongoing cancer-related clinical trials within the KCC; 2. The Clinical Research Management Office (CRMO) which provides strategic assistance and support to the CCRRC, DSMC, and continuous monitoring; 3. The Institutional Review Board (IRB) which has primary responsibility for the protection of the welfare of human subjects involved in biomedical and behavioral research. The IRB has full authority to approve, request modifications prior to approval, disapprove, suspend, or terminate for cause all research activities that fall within its jurisdiction; and 4. The Data and Safety Monitoring Committee (DSMC), which is responsible for data and safety monitoring of Kimmel Cancer Center investigator-initiated trials (KCC IIT).

数据和安全监控 Kimmel 癌症中心 (KCC) 的数据和安全监测计划 (DSMP) 规定了临床试验的监督和监测，以确保： 1.患者的安全；和 2. 这些试验中收集的数据的有效性和完整性。托马斯杰斐逊大学 (TJU) 的数据和安全监控职责在于： 1. 临床癌症研究审查委员会 (CCRRC)，负责监督 KCC 内所有新的和正在进行的癌症相关临床试验的科学审查； 2. 临床研究管理办公室（CRMO），为 CCRRC、DSMC 提供战略协助和支持，并持续监测； 3. 机构审查委员会 (IRB) 主要负责保护参与生物医学和行为研究的人类受试者的福利。 IRB 拥有全权批准、在批准前要求修改、不批准、暂停或因故终止属于其管辖范围内的所有研究活动；和 4. 数据和安全监测委员会（DSMC），负责金梅尔癌症中心研究者发起的试验（KCC IIT）的数据和安全监测。