Core--Clinical Trials Facility

核心——临床试验设施

基本信息

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
项目类别：
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

项目摘要

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).

临床试验核心在 Siteman 癌症中心 (SCC) 提供癌症临床试验的综合管理。核心的目标是提供基础设施和服务：。通过协助方案制定、资格审查、入组、临床监测、数据管理、数据分析和发布，支持研究者发起的试验的及时完成。。通过监控应计费用和方案合规性来维持质量保证标准，以满足临床试验目标。。支持SCC卫星及附属机构推广和管理SCC机构临床试验。。向所有 SCC 成员，特别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临床试验患者的多学科临床工作人员提供全面的临床试验信息。。确保在进行 SCC 机构临床试验时遵守所有机构、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测和审核准备数据要求。。根据良好临床研究实践的标准，为研究者和临床研究人员指导继续教育计划。。支持 SCC 研究者参与合作小组和行业发起的研究（以退款为基础）。