DATA SAFETY MONITORING PLAN

数据安全监控计划

• 批准号: 8249489
• 负责人: WALTER J. CURRAN
• 金额: $ 1.41万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8249489
• 关键词: Address; Adherence; Adverse event; Agreement; Annual Reports; Benefits and Risks; Cancer Center Support Grant; Case Study; Categories; Clinical; Clinical Research; Clinical Trials; Confidentiality; Consultations; Data; Data Protection; Devices; Distant; Dose; Drug Industry; Drug usage; Elements; Enrollment; Ensure; Faculty; Failure; Follow-Up Studies; Frequencies; Futility; Guidelines; Institutes; Institution; Institutional Review Boards; Laboratories; Lead; Malignant Neoplasms; Methods; Monitor; Monitoring Clinical Trials; Multicenter Trials; Nurse Administrator; Nurses; Nursing Research; Outcome; Participant; Personal Satisfaction; Pharmacologic Substance; Phase; Physician Executives; Policies; Principal Investigator; Privacy; Procedures; Process; Progress Reports; Protocols documentation; Recommendation; Regulatory Affairs; Reporting; Research Infrastructure; Research Personnel; Risk; Role; Safety; Schedule; Site; Specific qualifier value; Visit; Writing; base; cooperative study; data integrity; member; minimal risk; patient safety; phase 1 study; phase 3 study; programs; response; tumor; working group

Overview of DSMP: Every clinical study conducted by the Winship Cancer Institute (WCI) and its Clinical Trials Office (CTO) is required to have a data safety and monitoring plan (DSMP) that describes how the study will be audited for safety and data integrity including the reporting of adverse events. The general elements of a DSMP are (1) Adverse Event Reporting, including a description of adverse event determination/reporting procedures; proposed adverse event reporting schedules; determination regarding who is to receive adverse event reports; (2) Data, Safety and Progress Reporting with a timetable for data submission and monitoring; (3) Rules to trigger study closure including the rules and processes for implementing study closure based upon significant risks, benefits, or study futility determination and procedures and guidelines for unblinding/unmasking; (4) Methods for ensuring protection of data confidentiality and study privacy; and (5) Review of PI qualifications to conduct the particular clinical study for which DSMP is being considered. The Monitoring Office will coordinate, conduct and/or oversee all clinical trial monitoring. All investigatorinitiated interventional trials will be audited annually. The Monitoring Committee (DSMC) will review all reports of monitoring activities of active protocols annually. These reviews are in addition to the reporting requirements established by the IRB, which may include semi-annual as well as annual reports. The DSMC will also be responsible for overseeing all Phase I investigator-initiated trials.

DSMP 概述：Winship 癌症研究所 (WCI) 及其附属机构进行的每项临床研究 临床试验办公室 (CTO) 需要制定数据安全和监控计划 (DSMP)， 描述了如何对研究的安全性和数据完整性进行审核，包括不良反应的报告 事件。 DSMP 的一般要素是 (1) 不良事件报告，包括以下内容的描述： 不良事件确定/报告程序；拟议的不良事件报告时间表； 决定谁将接收不良事件报告； (2) 数据、安全与进步 报告数据提交和监测的时间表； (3) 触发研究结束的规则 包括根据重大风险实施研究结束的规则和流程， 好处，或研究无效性确定以及揭盲/揭露的程序和指南； (4) 确保保护数据机密性和研究隐私的方法； (5) PI审核 进行 DSMP 正在考虑的特定临床研究的资格。这 监测办公室将协调、进行和/或监督所有临床试验监测。所有调查员发起 干预试验将每年进行一次审计。监察委员会 (DSMC) 将审查 每年有关现行协议监测活动的所有报告。这些评论是除了 IRB 制定的报告要求，可能包括半年度和年度报告 报告。 DSMC 还将负责监督所有 I 期研究者发起的试验。