Data and Safety Monitoring

数据和安全监控

• 批准号: 8559579
• 负责人: GORDON D GINDER
• 金额: $ 1.71万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8559579
• 关键词: Cancer Center; Cancer Center Support Grant; Case Study; Clinical Research Associate; Clinical Trials; Conduct Clinical Trials; Data; Data Quality; Ensure; Guidelines; Individual; Institutional Review Boards; Massey Cancer Center at the Virginia Commonwealth University; Monitor; Multicenter Trials; Nursing Research; Policies; Protocol Compliance; Protocols documentation; Recommendation; Reporting; Research Personnel; Safety; Uncertainty; United States National Institutes of Health; Universities; Virginia; Writing; authority; data integrity; meetings

All clinical trials must have a written Data and Safety Monitoring (DSM) plan. Many clinical trials activated at the Virginia Commonwealth University (VCU) Massey Cancer Center (MCC) are multicenter trials and have a DSM plan that has been previously approved by an appropriate authority external to VCU. Although not required by NCI CCSG guidelines or NCI/NIH policy, the MCC default DSM plan for clinical trials is a DSMB. DSMBs evaluate ongoing trials for data integrity and subject safety. DSMB recommendations are reported to investigators and the IRB. If a DSMB identifies problems so serious as to raise doubts about the meaningfulness of the results of a trial, it also reports its findings to the Protocol Review and Monitoring Committee (PRMC). Although DSMBs make recommendations, the DSMB function is an advisory function. In addition to the DSMB, a DSM plan generally contains two other components: the Study Team and an Audit Committee (AC). The Study Team is the group primarily responsible for study conduct. In most cases, the study team consists of the Investigator(s), Study Biostatistician, a Research Nurse, a Clinical Research Associate, and a Regulatory Expert. Study teams meet regularly as appropriate for an individual study. ACs audit trials for regulatory compliance, protocol compliance, and data quality. AC findings are reported to the investigator and the trial DSMB. Although the AC may make recommendations, the AC function is a fact finding function.

所有临床试验都必须具有书面数据和安全监控（DSM）计划。在弗吉尼亚联邦大学（VCU）Massey癌症中心（MCC）激活的许多临床试验都是多中心试验，并且具有先前已由VCU外部适当机构批准的DSM计划。 尽管NCI CCSG指南或NCI/NIH政策不需要要求，但MCC的临床试验默认DSM计划是DSMB。 DSMBS评估正在进行的数据完整性和主题安全的试验。 DSMB建议向研究人员和IRB报告。如果DSMB确定了严重的问题，以提高对试验结果的有意义性的怀疑，它还向协议审查和监测委员会（PRMC）报告了其发现。尽管DSMB提出了建议，但DSMB功能 是咨询功能。 除DSMB外，DSM计划通常还包含其他两个组件：研究团队和审计委员会（AC）。 研究团队是主要负责研究行为的小组。在大多数情况下，研究团队由研究者，研究生物统计学家，研究护士，临床研究助理和监管专家组成。研究团队定期开会，适合个人研究。 ACS审计试验，用于法规符合性，协议合规性和数据质量。向研究人员和试验DSMB报告了交流发现。尽管AC可能会提出建议，但AC函数是事实查找功能。