DATA AND SAFETY MONITORING

项目总结 Winship癌症研究所(Winship)致力于保持所有临床研究的数据和安全监测的高标准。为了实现这一目标，Winship制定了一项数据和安全监测计划(DSMP)，以确保以下各项：所有研究参与者的安全；研究的合乎道德的进行；以及通过高质量的数据收集实现科学目标。一个独立的数据和安全监测委员会(DSMC)负责监督所有由研究人员发起的和合作的团体试验。该中心包括医生、研究护士、监测人员、一名统计学家和一名患者代表。 该委员会每月召开会议，审查正在进行的研究，确定潜在问题，并协助调查人员制定适当的纠正行动计划。 临床试验管理委员会与临床试验办公室以及临床和转化审查委员会的活动和管理是不同的，临床和转化审查委员会是方案审查和监测系统的组成部分。 该中心由Winship杰出的临床研究人员、血液学和内科肿瘤学副教授Suresh Ramalingam医学博士领导。

PROJECT SUMMARY The Winship Cancer Institute (Winship) is committed to maintaining high standards for data and safety monitoring of all clinical studies. To achieve this goal, Winship has developed a Data and Safety Monitoring Plan (DSMP) to ensure the following: the safety of all research participants; the ethical conduct of studies; and the achievement of scientific goals through high-quality data collection. An independent data and safety monitoring committee (DSMC) is charged with oversight of all investigator-Initiated and cooperative group trials. The DSMC includes physicians, research nurses, monitors, a statistician and a patient representative. This committee meets on a monthly basis to review ongoing studies, identify potential problems and assists investigators with developing appropriate corrective action plans. The DSMC is distinct and separate from the activities and management of the Clinical Trials Office and from the Clinical and Translational Review Committee which is an integral part of the Protocol Review and Monitoring System. The DSMC is led by one of Winship's outstanding clinical investigators, Suresh Ramalingam, M.D., associate professor of Hematology and Medical Oncology.