Clinical Protocol and Data Management

临床方案和数据管理摘要 摩尔癌症中心(MCC)临床试验办公室(CTO)为开展这项工作提供了集中的资源 加州大学圣地亚哥分校(UCSD)癌症相关临床研究，包括附属RADY 儿童医院。CTO的目的是提供有效和高效的基础设施来支持 参与MCC所有癌症临床研究的开发、实施和报告。 摩尔癌症中心临床试验办公室提供以下服务： ·作为中央临床研究信息库，促进中心范围内的沟通， 所有临床研究从初始到最终的受试者应计跟踪和进度监测 出版。 ·协助MCC调查人员及时启动和管理临床研究，包括 科学、伦理、财务和业务审查所需的准备和沟通 作为对年度监管审查的持续支持。 ·协助临床医生筛选和招募患者参加临床研究研究。 ·协调并确保完成针对患者的研究要求。 ·为临床研究提供数据管理支持。 ·为内部和外部质量和合规审计准备医疗和研究记录。 ·向首席技术官工作人员和调查人员提供临床研究培训和教育，了解 进行临床研究。 ·执行质量保证活动并监督符合联邦要求的情况，如研究 注册到Clinicaltrials.gov和NCI的临床试验报告计划。 ·向MCC医生、参考医生和公众传达临床研究的可用性。

CLINICAL PROTOCOL & DATA MANAGEMENT ABSTRACT The Moores Cancer Center (MCC) Clinical Trials Office (CTO) provides a centralized resource for the conduct of cancer-related clinical research at University of California San Diego (UCSD) including the affiliated Rady Children’s Hospital. The purpose of the CTO is to provide an effective and efficient infrastructure to support MCC investigators in developing, implementing, and reporting on all cancer clinical research studies at MCC. The Moores Cancer Center Clinical Trials Office provides the following services: · Serves as a central clinical research information repository that facilitates Center-wide communications, subject accrual tracking, and monitoring of the progression for all clinical studies from inception to final publication. · Assists MCC investigators in the timely activation and administration of clinical studies, including the preparations and communications required for scientific, ethical, financial, and operational reviews as well as ongoing support for annual regulatory reviews. · Assists clinicians in screening and enrolling patients for clinical research studies. · Coordinates and ensures the completion of patient-specific study requirements. · Provides data management support for clinical research studies. · Prepares medical and research records for internal and external quality and compliance audits. · Provides clinical research training and education to CTO staff and investigators related to best practices in conducting clinical research. · Performs quality assurance activities and monitors compliance with federal requirements such as study registration to clinicaltrials.gov and NCI’s Clinical Trials Reporting Program. · Communicates the availability of clinical studies to MCC physicians, referring physicians, and the public.