Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 9467452
• 负责人: ANDRES FORERO
• 金额: $ 33.42万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 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/9467452
• 关键词: Adherence; Alabama; Area; Cancer Center; Catchment Area; Charge; Clinical Cancer Center; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Design; Comprehensive Cancer Center; Data; Data Collection; Data Quality; Databases; Disease; Enrollment; Ensure; Environment; Ethics; Ethnic group; Extramural Activities; Faculty; Gender; Gene therapy trial; Grant; Industry; Institutes; Institution; Malignant Neoplasms; Measures; Minority Recruitment; Monitor; Monitoring Clinical Trials; NCI Center for Cancer Research; National Cancer Institute; Participant; Patients; Phase; Play; Population; Procedures; Process; Protocols documentation; Quality Control; Race; Regulation; Reporting; Research Activity; Research Infrastructure; Research Personnel; Role; Safety; Specialized Program of Research Excellence; System; Time; Toxic effect; Training and Education; Translational Research; Universities; Update; Work; cancer clinical trial; clinical care; clinical investigation; data management; demographics; design; experience; high standard; improved; investigator-initiated trial; meetings; member; operation; patient safety; protocol development; quality assurance; recruit; response; tumor; working group

CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) ABSTRACT The Clinical Protocol and Data Management (CPDM) of the University of Alabama at Birmingham (UAB) Comprehensive Cancer Center (CCC) is charged with maintaining the highest standards of clinical investigation that are aligned with all UAB, state and federal regulations, while assisting investigators in protocol development and maintaining efficient processes related to clinical investigations. The CPDM is responsible for the following significant functions: 1) Coordination, tracking, and reporting of all cancer clinical research activity undertaken at UAB, 2) Continuous improvement of the clinical trial activation process, 3) Ongoing education and training of clinicians and clinical research staff, 4) Clinical trial data quality monitoring, 5) Cancer clinical trial participant safety, and 6) Actively ensuring all sections of the population represented in the UAB CCC's catchment area have the opportunity to be represented in cancer clinical trials. CPDM adds value to the work of the UAB CCC members by providing support for protocol development as well as navigating the PRMS approval process, and assuring that there is knowledgeable and professional support for investigators at all stages of experience with the clinical trials process. The CPDM accomplishes this objective by providing centralized critical staff and infrastructure for all aspects of clinical research coordination and activation, as well as the efficient, and ethical conduct of open protocols. It provides the monitoring of the studies and all aspects of quality assurance. In addition, the CPDM provides a centralized database of protocol-specific data. This robust organization assures that all clinical trials have excellent support in protocol adherence, regulatory compliance, and recruitment (especially minority recruitment). Outstanding clinical trial support and quality of the CPDM are demonstrated by a number of objective measures described below; four FDA audits over the last 15 years (3 for high enrollment in FDA pivotal clinical trials and 1 for a gene therapy trial) resulted with no 483 forms being issued. Patient enrollment has increased over the last three years, especially to investigator-initiated and early phase clinical trials. The CPDM has taken steps to modify the staff and improve the infrastructure in response to the changes in UAB CCC research emphasis and faculty, and to the changing regulatory environment over the past five years: 1. The CPDM has relocated to the newly renovated Wallace Tumor Institute; 2. The CPDM has implemented OnCore®, a comprehensive clinical trials management system; 3. The CPDM has implemented the Clinical Trials Monitoring Committee (CTMC); this committee monitors in real time active clinical trials in the UAB CCC for patient safety; 4. The CPDM has incorporated specialized protocol management teams who have enhanced both investigator-coordinator interaction and accrual to trials in high-priority areas. In summary, the CPDM has expanded its capacity and aligned its focus with the changing needs of UAB CCC members. CPDM continues to provide excellent coordinating and monitoring support.

临床方案和数据管理(CPDM) 摘要 阿拉巴马大学伯明翰分校的临床方案和数据管理(CPDM) 综合癌症中心(CCC)负责维持最高标准的临床 符合所有UAB、州和联邦法规的调查，同时协助调查人员 制定和维护与临床研究相关的有效流程。CPDM是 负责以下重要职能：1)协调、跟踪和报告所有癌症临床 在UAB开展的研究活动，2)临床试验激活过程的持续改进，3) 对临床医生和临床研究人员进行持续的教育和培训，4)临床试验数据质量监测， 5)癌症临床试验参与者的安全，以及6)积极确保参与试验的所有人群 UAB CCC的集水区有机会代表癌症临床试验。CPDM添加 对UAB CCC成员的工作提供支持，支持方案制定以及 浏览PRMS审批流程，并确保获得以下方面的专业知识支持 研究人员在临床试验过程的所有阶段的经验。CPDM实现了这一目标 通过为临床研究协调和所有方面提供集中的关键员工和基础设施 激活，以及开放协议的高效和合乎道德的行为。它提供了对 学习和各方面的质量保证。此外，CPDM提供了一个集中的数据库 协议特定的数据。这一强大的组织确保了所有临床试验在方案上都得到了极好的支持 遵守、合规和招聘(特别是少数族裔招聘)。杰出的临床试验 CPDM的支持和质量体现在下述一些客观措施上； FDA在过去15年中的审计(3项FDA关键临床试验高登记，1项基因疗法 审判)的结果是没有发出483份表格。在过去的三年里，患者的登记人数有所增加， 尤其是研究人员发起的和早期临床试验。CPDM已采取措施修改工作人员 并改善基础设施，以应对大学联合技术中心研究重点和师资的变化，以及 五年来不断变化的监管环境：1.CPDM搬迁到新的 翻新华莱士肿瘤研究所；2.CPDM已经实施了全面的临床试验OnCore® 管理制度；3.CPDM已实施临床试验监测委员会(CTMC)； 委员会实时监测UAB CCC中积极的临床试验，以确保患者安全；4.CPDM具有 合并了专门的礼仪管理团队，他们增强了调查员-协调员 高优先领域试验的相互作用和应计收益。总而言之，CPDM扩大了其能力并 使其重点与UAB CCC成员不断变化的需求相一致。CPDM继续提供出色的 协调和监督支持工作。