Clinical Protocol and Data Management: (Core 011)

临床方案和数据管理：（核心 011）

• 批准号: 9359376
• 负责人: Anthony Boutros El-Khoueiry
• 金额: $ 46.45万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9359376
• 关键词: Asians; Awareness; Budgets; Catchment Area; Center Core Grants; Certification; Charge; Clinical; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Communities; Conduct Clinical Trials; Consult; Consultations; Contracts; Data; Data Quality; Development; Disease; Dose; Education; Effectiveness; Eligibility Determination; Ensure; Evaluable Disease; Fostering; Goals; Growth; Hispanics; Hospitals; Institutional Review Boards; Life Cycle Stages; Malignant Neoplasms; Minority; Modality; Monitor; Operations Research; Pacific Island Americans; Participant; Patients; Performance; Phase; Physician Executives; Policies; Procedures; Process; Protocols documentation; Regulatory Affairs; Reporting; Research; Research Infrastructure; Research Personnel; Retirement; Risk stratification; Safety; Safety Management; Seasons; Services; Specimen; Supervision; Therapeutic Intervention; Therapeutic Trials; Time; Toxic effect; Training; USC/Norris Comprehensive Cancer Center and Hospital; Woman; adjudication; authority; base; clinical investigation; data integrity; data management; design; experience; improved; minority children; minority communities; patient safety; programs; protocol development; quality assurance; tool

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.

项目总结/摘要 临床方案和数据管理（CPDM）职责由USC Norris Clinical 调查支助办公室。作为USC Norris的集中临床试验办公室，CISO 管理，协调和提供全方位的服务，并帮助确保高 以安全、合规和高效的方式开展高质量的癌症临床研究。CISO协助调查人员 方案制定并促进对激活过程的审查。它还直接负责：1） 招聘、培训和监督临床研究人员; 2）质量保证; 3）政策和程序 与临床试验进行有关; 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的医学总监是Anthony El-Khoueiry，医学博士，他是一位经验丰富的癌症临床医生。 trialist.他得到了助理医学主任Kevin Kelly医学博士的支持。首席信息安全官的副总监，凯 约翰逊，注册护士，宣布她退休后，2014年超过20年的服务，但继续作为一个 在全国范围内进行搜索的同时，我们还聘请了一名顾问，以确保平稳过渡。日常活动是 由两名经验丰富的经理，临床研究运营助理总监和 法规事务部助理总监。南加州大学诺里斯分校还聘请休伦咨询公司， 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益。特别 值得注意的是，南加州大学决定在企业范围内实施OnCore，并修改合同， 预算编制过程。协议周转率大幅下降，而IIT的数量 增加介入性治疗试验的应计费用显示出增长， 试验合格性标准的复杂性。其他成就包括建立了一个前PRMS 设计和可行性咨询服务，制定相关标准操作程序， 研究行为，雇用教育协调员，以及国家研究认证 协调员。 在临床试验参与方面，南加州大学诺里斯分校继续以其成功的策略为基础 采取多管齐下的办法，促进少数群体的融入。西班牙裔和亚太岛民 代表南加州大学诺里斯集水区两个最大的少数民族社区。2013年，西班牙裔 占USC Norris医院新发癌症病例的40.5%，占介入治疗应计病例的44.8%。 治疗试验在南加州大学诺里斯医院，亚洲/太平洋岛民占新发癌症的14.3%， 11.3%的参与者参与了干预性治疗试验。