Core--Clinical Trials Facility

核心——临床试验设施

• 批准号: 6998206
• 负责人: Jeff M Michalski
• 金额: $ 22.87万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-21 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6998206
• 关键词: biomedical facility; clinical trials; health science research support; neoplasm /cancer; neoplasm /cancer therapy

The Clinical Trials Core provides integrated management of cancer clinical trials at the Siteman Cancer Center (SCC). The objectives of the Core are to provide an infrastructure and services that: . Support timely completion of investigator-initiated trials by assisting with protocol development, eligibility review, enrollment, clinical monitoring, data management, data analysis and publication. . Maintain quality assurance standards by monitoring accrual and protocol compliance to meet clinical trial objectives. . Support SCC satellites and affiliates with the promotion and management of SCC institutional clinical trials. . Provide comprehensive clinical trial information to all SCC members, especially to multidisciplinary disease focus groups in the Translational and Clinical Research Program and to the multidisciplinary clinic staff who review patients for clinical trials. . Ensure compliance with all institutional, state, and federal regulations in the conduct of SCC institutional clinical trials, including regulatory policies and management of investigational drugs. . Prepare data for NCI, FDA, industry or cancer center quality assurance monitoring and auditing requirements. . Direct continuing education programs for investigators and clinical research staff according to standards of good clinical research practice. . Support SCC investigator participation in cooperative group and industry-initiated studies (on a chargeback basis).

临床试验核心提供了现场癌症中心（SCC）的癌症临床试验的综合管理。核心的目标是提供一个基础架构和服务： 。通过协助协议开发，资格审查，入学，临床监测，数据管理，数据分析和发布，支持及时完成研究者发起的试验。 。通过监视应计和协议合规性以实现临床试验目标来保持质量保证标准。 。通过促进和管理SCC机构临床试验，支持SCC卫星和分支机构。 。向所有SCC成员提供全面的临床试验信息，尤其是转化和临床研究计划中的多学科疾病焦点小组，以及审查患者临床试验患者的多学科诊所员工。 。确保在SCC机构临床试验中遵守所有机构，州和联邦法规，包括监管政策和研究药物的管理。 。为NCI，FDA，行业或癌症中心质量保证监控和审计准备数据 要求。 。根据良好的临床研究实践标准，针对研究人员和临床研究人员的直接继续教育计划。 。支持SCC研究者参与合作小组和行业发起的研究（基于退款）。