Core--Clinical Trials Facility

临床试验核心为西特曼癌症中心(SCC)提供癌症临床试验的综合管理。核心的目标是提供以下基础设施和服务： 。通过协助制定方案、资格审查、登记、临床监测、数据管理、数据分析和发布，支持及时完成由研究人员发起的试验。 。通过监测应计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卫星和附属机构推动和管理SCC机构临床试验。 。向所有SCC成员提供全面的临床试验信息，特别是向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的多学科诊所工作人员。 。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计准备数据 要求。 。根据良好的临床研究实践标准，指导研究人员和临床研究人员的继续教育计划。 。支持SCC调查员参与合作小组和行业发起的研究(按存储容量使用计费)。

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).