Clinical Protocol and Data Management: (Core 011)

临床方案和数据管理：（核心 011）

• 批准号: 8999047
• 负责人: Anthony Boutros El-Khoueiry
• 金额: $ 27.45万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-12-01 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8999047
• 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; Diagnostic and Statistical Manual of Mental Disorders; Disease; Dose; Education; Effectiveness; Eligibility Determination; Ensure; Fostering; Goals; Growth; Hispanics; Hospitals; Institutional Review Boards; Life Cycle Stages; Malignant Neoplasms; Minority; Modality; Monitor; Pacific Island Americans; Participant; Patients; Performance; Phase; Physician Executives; Policies; Procedures; Process; Protocols documentation; Regulatory Affairs; Reporting; Research; Research Infrastructure; Research Personnel; Retirement; Risk; Safety; Safety Management; Seasons; Services; Specimen; Stratification; Therapeutic Trials; Time; Toxic effect; Training; USC/Norris Comprehensive Cancer Center and Hospital; Woman; abstracting; adjudication; authority; base; clinical investigation; data management; data quality/integrity; design; experience; improved; meetings; minority children; operation; 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/文摘