Clinical Protocol and Data Management: (Core 011)

项目摘要/摘要 临床方案和数据管理(CPDM)责任由南加州大学诺里斯临床中心履行 调查支助办公室(CISO)。作为南加州大学诺里斯分校的中央临床试验办公室 管理、协调和提供全方位的服务，并帮助确保高 以安全、合规和高效的方式进行高质量的癌症临床研究。CISO协助调查人员 协议的制定，并促进对激活过程的审查。它还直接负责：1) 聘用、培训和监督临床研究人员；2)质量保证；3)政策和程序 与临床试验有关；4)支持和协调临床研究委员会(PRMS， DSM，质量保证)；5)指标和报告。 CISO的医务总监是Anthony El-Khoueary医学博士，他是一位经验丰富的癌症临床医生 三人组。他得到了医学助理医务主任凯文·凯利的支持。CISO副主任Kay 约翰逊，RN，在服务了20多年后于2014年宣布退休，但继续担任 在全国范围内进行搜索的同时，请他担任顾问以确保平稳过渡。日常活动包括 由两名经验丰富的经理负责，负责临床研究运作的助理总监和 主管监管事务的助理署长。南加州大学诺里斯分校还聘请了休伦咨询公司来确定 改进战略并帮助CISO应对持续增长和复杂的 临床研究计划。 CISO在项目期间成功地提高了效率和效力。特别的 请注意，南加州大学决定在整个企业范围内实施OnCore，并修改合同和 预算编制流程。议定书周转率大幅下降，而信息技术研究所的数量 增加了。介入治疗试验的收益显示出增长，尽管 试验资格标准的复杂性。其他成就包括建立了一个预制项目管理系统 提供设计和可行性咨询服务，制定相关标准作业程序 研究行为，雇用教育协调员，以及国家研究认证 协调人。 在参与临床试验方面，南加州大学诺里斯分校继续建立其成功的战略 采取多管齐下的办法，将少数群体纳入其中。拉美裔和亚太岛民 代表南加州大学诺里斯集水区最大的两个少数民族社区。2013年，拉美裔美国人 占南加州大学诺里斯医院新发癌症病例的40.5%，占介入治疗收益的44.8% 治疗试验。亚洲/太平洋岛民占南加州大学诺里斯医院和 11.3%的收益用于介入治疗试验。

Project Summary/Abstract Clinical Protocol and Data Management (CPDM) responsibilities are fulfilled by the USC Norris Clinical Investigations Support Office (CISO). As the centralized clinical trials office for USC Norris, CISO manages, coordinates and provides a full range of services and helps to assure the conduct of high quality cancer clinical research in a safe, compliant and efficient manner. CISO assists investigators in protocol development and facilitates the review to activation process. It is also directly responsible for: 1) hiring, training and supervising clinical research staff, 2) quality assurance; 3) policies and procedures related to clinical trials conduct; 4) support and coordination of clinical research committees (PRMS, DSM, Quality Assurance); 5) metrics and reporting. The Medical Director of CISO is Anthony El-Khoueiry, MD, a highly experienced cancer clinical trialist. He is supported by Assistant Medical Director, Kevin Kelly, MD. CISO's Associate Director, Kay Johnson, RN, announced her retirement in 2014 after more than 20 years of service but continues as a consultant to ensure a smooth transition while a national search is on-going. Day to day activities are handled by two seasoned managers, the Assistant Director for Clinical Research Operations and Assistant Director for Regulatory Affairs. USC Norris has also engaged Huron Consulting to identify strategies for improvement and to help CISO respond to the continued growth and complexity of the clinical research program. CISO has successfully improved efficiency and effectiveness during the project period. Of particular note is USC's decision to implement OnCore enterprise-wide and to revamp the contracting and budgeting processes. Protocol turnaround has declined substantially while the number of IITs has increased. Accrual to interventional therapeutic trials has shown growth despite the increasing complexity of trial eligibility criteria. Other accomplishments include the establishment of a pre-PRMS design and feasibility consultation service, the development of standard operating procedures related to study conduct, the hiring of an education coordinator, and the national certification of research coordinators. In regards to clinical trials participation, USC Norris has continued to build on its successful strategies for the inclusion of minorities using a multi-prong approach. Hispanics and Asian Pacific Islanders represent the two largest minority communities in the USC Norris catchment area. In 2013, Hispanics represented 40.5% of new cancer cases at USC Norris hospitals and 44.8% of accrual to interventional therapeutic trials. Asian/Pacific Islanders represented 14.3% of new cancers at USC Norris hospitals and 11.3% of accrual to interventional therapeutic trials.