Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 9099665
• 负责人: Michael B Kastan
• 金额: $ 19.44万
• 依托单位: DUKE UNIVERSITY
• 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/9099665
• 关键词: Adult; African American; Applications Grants; Cancer Center Support Grant; Cancer Patient; Childhood; Clinical; Clinical Data; Clinical Protocols; Clinical Research; Clinical Research Protocols; Clinical Trials; Collaborations; Communities; Data; Data Analyses; Data Collection; Data Quality; Databases; Development; Eligibility Determination; Enrollment; Ensure; Environment; Grant; Information Technology; Institutes; Joints; Malignant Neoplasms; Monitor; Monitoring Clinical Trials; Participant; Patient Recruitments; Patients; Performance; Process; Protocols documentation; Quality Control; Recruitment Activity; Reporting; Research; Research Infrastructure; Research Personnel; Research Project Grants; Research Subjects; Resource Sharing; Safety; Services; Technology; Therapeutic Trials; Time; Training; Training and Education; Woman; anticancer research; base; cancer clinical trial; data management; design; electronic data; meetings; member; novel therapeutics; oncology; programs; quality assurance; therapy development; tool; web site

ABSTRACT The Clinical Trials Office (CTO) provides Protocol and Data Management (CPDM) services to all oncology research projects. The CTO provides infrastructure for oversight and quality control functions, including centralized education and training services for clinical research personnel. The CPDM services are a joint effort between staff in the Cancer Protocol Committee (CPC), clinical trials monitoring team, Safety Oversight Committee (SOC), and DCI Information Technology (IT) shared resource to provide start-to-finish clinical trials services to Cancer Institute members. The PRMS administration by the CPC, quality assurance and research compliance by the monitoring team, data and safety monitoring by the SOC, database development & management by the IT shared resource are all centralized. The CPDM central infrastructure is essential to develop and manage an IT environment that is required to develop databases, and train the users to collect, track, and generate reports for the DCI clinical trial portfolio. This central CPDM approach permits the DCI to assess the DCI clinical trials portfolio, its performance, and its alignment with DCI priorities. It allows the DCI to engage the cancer patient community and recruit potential research subjects by providing information on the DCI website about trials that are open to enrollment. It supports the ability of DCI members to report portfolio metrics in large collaboration-based grant applications such as the CCSG, UM1, NCTN, and various SPORE grants. It enables the PRMS to analyze data on protocol startup and approval times in order to identify gaps in review process efficiency. It also permits the DCI to comply with federally-mandated ClinicalTrials.gov and NCI Clinical Trials Reporting Program (CTRP) requirements. The CPDM facilitates design and development of clinical trials in a 21CFR Part 11 compliant electronic data capture platforms such as Oracle Clinical (C3D) and NCI approved Medidata Rave. All cancer research participants are registered in eResearch database. In the last five years a total of 15,028 adult subjects and 751 pediatric subjects were enrolled in cancer research trials at Duke; 9,681 adult subjects in therapeutic trials and 5,347 adult subjects in non-therapeutic trials. The adult subject enrollment included 8,495 (57%) of women and 2,268 (15%) of African Americans. The CPDM ongoing effort is to enhance the use of technology to efficiently collect, manage and share clinical research information with DCI members, cancer patients, and external collaborators.

抽象的 临床试验办公室（CTO）为所有肿瘤学提供协议和数据管理（CPDM）服务 研究项目。 CTO为监督和质量控制功能提供基础架构，包括 临床研究人员的集中教育和培训服务。 CPDM服务是联合的 癌症协议委员会（CPC）员工之间的努力，临床试验监测团队，安全监督 委员会（SOC）和DCI信息技术（IT）共享资源，以提供从头到尾的临床试验 为癌症研究所成员提供服务。 CPC的PRMS政府，质量保证和研究 监测团队，数据和数据库开发的数据和安全监控的遵守 IT共享资源的管理都是集中的。 CPDM中央基础设施对于 开发和管理开发数据库所需的IT环境，并培训用户收集， 跟踪并生成DCI临床试验组合的报告。这种中央CPDM方法允许DCI到达 评估DCI临床试验组合，其性能以及与DCI优先级的一致性。它允许DCI 通过提供有关癌症患者社区并招募潜在研究主题的信息 DCI网站有关开放招生的试验。它支持DCI成员报告投资组合的能力 CCSG，UM1，NCTN和各种孢子等大型基于协作的赠款应用程序中的指标 赠款。它使PRM可以分析协议启动和批准时间的数据，以确定差距 审查过程效率。它还允许DCI遵守联邦临床的临床。 临床试验报告计划（CTRP）要求。 CPDM促进了设计和开发 21CFR第11部分中符合电子数据捕获平台的临床试验，例如Oracle临床（C3D）和 NCI批准了Medidata狂欢。所有癌症研究参与者均在Eresearch数据库中注册。在 最近五年总共招募了15,028名成人受试者和751名儿科受试者 在杜克在非治疗试验中，有9,681名治疗试验中的成年受试者和5,347名成人受试者。成人 受试者入学率包括8,495名（57％）的妇女和2,268名（15％）的非裔美国人。 CPDM正在进行 努力是增强技术的使用来有效收集，管理和共享临床研究信息 与DCI成员，癌症患者和外部合作者。