Data and Safety Monitoring/ NIH Policy

数据和安全监测/ NIH 政策

• 批准号: 8901951
• 负责人: Thomas James Lynch
• 金额: $ 7.21万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8901951
• 关键词: Address; Affect; Basic Science; Cancer Center Support Grant; Clinical Research; Clinical Trials; Comprehensive Cancer Center; Conduct Clinical Trials; Data; Ensure; Event; Faculty; Good Clinical Practice; Head; Institution; Institutional Review Boards; Laboratories; Malignant Neoplasms; Medicine; Monitor; Nature; Participant; Patients; Phase; Policies; Principal Investigator; Protocols documentation; Records; Reporting; Research; Research Ethics; Research Misconduct; Research Personnel; Review Committee; Risk; Role; Rosa; Safety; Schedule; Therapeutic; Training Programs; Treatment Protocols; United States National Institutes of Health; Yale Cancer Center; arm; authority; experience; follow-up; patient safety; professor; protocol development; Address; Affect; Basic Science; Cancer Center Support Grant; Clinical Research; Clinical Trials; Comprehensive Cancer Center; Conduct Clinical Trials; Data; Ensure; Event; Faculty; Good Clinical Practice; Head; Institution; Institutional Review Boards; Laboratories; Malignant Neoplasms; Medicine; Monitor; Nature; Participant; Patients; Phase; Policies; Principal Investigator; Protocols documentation; Records; Reporting; Research; Research Ethics; Research Misconduct; Research Personnel; Review Committee; Risk; Role; Rosa; Safety; Schedule; Therapeutic; Training Programs; Treatment Protocols; United States National Institutes of Health; Yale Cancer Center; arm; authority; experience; follow-up; patient safety; professor; protocol development

The Yale Cancer Center is committed to ensuring the safety of patients participating in clinical trials and requires all clinical trials conducted at the YCC adhere to the Yale Cancer Center (YCC) Data and Safety Monitoring Plan (DSMP). The original NCI approved./YCC DSMP was recently revised and approved by NCI in July of 2011. The plan outlines the scope of protocol oversight which is operationalized by the YCC Data and Safety Monitoring Committee (DSMC). While each investigator is responsible for the monitoring of a study, the initial scientific review conducted by the YCC Protocol Review Committee (PRC) includes the assignment of a more detailed protocol specific plan requiring additional oversight provided by the DSMC. For studies without external monitoring this includes a protocol specific schedule for safety review and internal auditing. The development of protocol specific monitoring plans and reporting requirements are dependent upon the overall risk to patients, the nature of the agent, the phase of the trial and prior safety data with the proposed treatment regimen, the role of the Yale principal investigator and the institution, and the study sponsor. The purpose of the DSMC is to provide ongoing data and safety monitoring for all interventional cancer clinical trials. The DSMC reviews all studies at least annually and has the authority to intervene in the conduct of these studies as necessary to ensure the safety of the participants and to maintain the highest quality in the clinical research performed at YCC. The Committee reviews safety data, audit findings, reports of unanticipated events, protocol deviations and requests for specific reviews from faculty, staff or study participants. The DSMC is chaired by Michal Rose, MD, Associate Professor of Medicine, and the Vice Chair is Ed Snyder, MD Professor of Laboratory Medicine each with over 13 years of clinical trials experience. The Office of Protocol Review and Monitoring (OPRM), headed by Susan Anderson, is the administrative arm of the DSMC which coordinates all DSMC activities, maintains records of all DSMC actions and provides staffing for internal audits and follow up on actions required as a resiJit of DSMC review or finding. OPRM also coordinates training programs for faculty and research staff, including. Good Clinical Practices (GCP), IRB Basics, Research Ethics and Misconduct, as well as specific topics key to the understanding of compliance and safety as they are identified and addressed as required.

耶鲁癌症中心致力于确保参加临床试验的患者的安全 需要在YCC遵守耶鲁癌症中心（YCC）数据和安全性的所有临床试验 监视计划（DSMP）。最初的NCI批准。/YCCDSMP最近已由NCI修订和批准 2011年7月。该计划概述了由YCC数据实现的协议监督范围 和安全监测委员会（DSMC）。每个研究人员负责监视 研究，由YCC协议审查委员会（PRC）进行的初步科学审查包括 分配更详细的协议特定计划，需要DSMC提供的其他监督。 对于没有外部监控的研究，这包括针对安全审查的协议时间表， 内部审计。协议特定监控计划和报告要求的开发是 取决于患者的总体风险，代理的性质，试验阶段和先前的安全 使用拟议的治疗方案，耶鲁大学首席研究员和机构的作用以及 研究赞助商。 DSMC的目的是为所有介入癌症提供持续的数据和安全监控 临床试验。 DSMC至少每年审查所有研究，并有权干预 必要的进行这些研究以确保参与者的安全并保持最高 在YCC进行的临床研究质量。委员会审查安全数据，审核调查结果，报告 意外事件，协议偏差以及教职员工或学习的特定评论请求 参与者。 DSMC由医学副教授Michal Rose主持，副教授 主席是医学博士实验室医学教授Ed Snyder，每个教授都有13年以上的临床试验 经验。由苏珊·安德森（Susan Anderson）领导的协议审查与监视办公室（OPRM）是 DSMC的行政部门协调所有DSMC活动，维护所有DSMC的记录 行动并为内部审核提供人员配备，并跟进DSMC审查重新审查所需的行动 或发现。 OPRM还协调教师和研究人员的培训计划，包括。良好的临床 实践（GCP），IRB基础知识，研究伦理和不当行为，以及特定主题的关键 根据需要识别和解决合规性和安全性。