DATA AND SAFETY MONITORING

数据和安全监控

• 批准号: 7414810
• 负责人: PETER D. EMANUEL
• 金额: $ 9.15万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-05-01 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7414810
• 关键词: Adherence; Adverse event; Clinical Investigator; Clinical Research; Comprehensive Cancer Center; Data; Data Quality; Grant; Human Resources; Monitor; Monitoring Clinical Trials; Nursing Research; Pharmacy facility; Policies; Procedures; Process; Protocols documentation; Reporting; Research Ethics Committees; Review Committee; Safety; Time; United States Food and Drug Administration; human subject; improved; quality assurance

DESCRIPTION (provided by applicant): Since the last submission of this grant, the requirements for assurance of adherence to protocol-specific procedures and rules of human subjects' protection have increased. The requirements have been the result of national (FDA, OHRP, NCI) and local IRB policies. The NCI now requires that each Comprehensive Cancer Center develop an approved DSMP. We have significantly enhanced our monitoring and oversight activities and this has resulted in improved data quality and protocol adherence. However, these improvements have resulted in significant increases in personnel commitments and expense. The process we use for safety and protocol progress review is rigorous using a Clinical Trial Monitoring Review Committee meeting which meets weekly and reviews all active protocols for accrual, adverse events, and problems in "real time". The meetings are chaired by the Associate Director for Clinical Research and involve multiple clinical investigators, research nurses, data managers, pharmacy and regulatory staff. Weekly reports of safety/adverse events are referred to our Quality Assurance Committee (QAC) Director (Dr Carla Falkson) for review. Routine and "for cause" audits are coordinated by the QAC with reports to the Center Director, IRB and regulatory agencies as appropriate.

描述（由申请人提供）：自上次提交本拨款以来，确保遵守特定方案程序和人类受试者保护规则的要求有所增加。 这些要求是国家（FDA、OHRP、NCI）和地方 IRB 政策的结果。 NCI 现在要求每个综合癌症中心制定经批准的 DSMP。 我们显着加强了监测和监督活动，从而提高了数据质量和协议遵守情况。 然而，这些改进导致人员投入和费用显着增加。 我们用于安全性和方案进展审查的流程非常严格，使用临床试验监测审查委员会会议，该会议每周举行一次会议，并“实时”审查所有现行方案的应计、不良事件和问题。 会议由临床研究副主任主持，涉及多名临床研究者、研究护士、数据管理员、药房和监管人员。 安全/不良事件的每周报告将提交给我们的质量保证委员会 (QAC) 主任（Carla Falkson 博士）进行审查。 例行审核和“有因”审核由 QAC 协调，并向 中心主任、IRB 和适当的监管机构。