Clinical, Protocol and Data Management

临床、方案和数据管理

• 批准号: 10439832
• 负责人: Martha P. Mims
• 金额: $ 30.26万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10439832
• 关键词: Agreement; Ambulatory Care; Amendment; Award; Budgets; Cancer Center; Cancer Center Support Grant; Catchment Area; Clinical; Clinical Data; Clinical Investigator; Clinical Nursing Research; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Support Unit; Comprehensive Cancer Center; Data; Databases; Disease; Elderly; Ensure; Event; Hospitals; Human Resources; Individual; Informatics; Institutional Review Boards; Intervention Trial; Maintenance; Malignant Neoplasms; Mediation; Medicine; Monitor; Nurses; Outcome; Patients; Preparation; Protocols documentation; Quality Control; Regulatory Affairs; Reporting; Research; Research Personnel; Research Support; Risk; Safety; Services; Training; Training and Education; Woman; Work; clinical development; college; data management; experience; member; minority children; operation; participant safety; patient registry; patient safety; programs; quality assurance; research study; working group

CPDM PROJECT SUMMARY The Clinical Protocol and Data Management component of the Dan L Duncan Comprehensive Cancer Center (DLDCCC) includes the Clinical Trials Support Unit (CTSU) and the Data Review and Safety Monitoring Committees. The CTSU provides central management, research support, and oversight functions for the conduct of cancer-related clinical trials at all ambulatory care centers and hospitals that are part of the DLDCCC. CTSU services are available to all members of the DLDCCC engaged in clinical research. The major functions of the CTSU are to provide: 1. Assistance with regulatory and administrative matters relating to clinical research and trials, including IRB compliance and approval, ongoing amendments and renewal, external agency compliance (such as the FDA), and maintenance of regulatory files, 2. Clinical trials informatics expertise, in particular maintaining an electronic database of cancer-related clinical protocols, patient registry and clinical data, and monitoring and reporting on accrual, 3. Quality Assurance/Quality Control auditing and personnel training to ensure that the research team is trained in best practices in clinical research, and 4. Research nursing/clinical trials management. In the most recent year 01/01/2018–12/31/2018, the CTSU supported 224 interventional trials including 54 investigator-initiated studies, 30 of which are conducted under IND and 3 under an IDE. The Data Review and Safety Monitoring Committees are separate from the operational aspect of clinical trials managed by the CTSU and function to ensure the safety of participants, the validity of data, and the appropriate termination of studies in the event that undue risks have been uncovered, or it appears that trials cannot be conducted successfully. The DLDCCC patient safety officer ensures that all data monitoring for Cancer Center trials is conducted in accordance with the approved monitoring plan. The CPDM also monitors accrual to ensure there is appropriate representation of women, minorities, children, and older adults in clinical research.

CPDM项目总结 Dan L邓肯综合癌症中心的临床方案和数据管理组件 （DLDCCC）包括临床试验支持单位（CTSU）和数据审查和安全性监测 委员会。CTSU为行为提供中央管理，研究支持和监督职能 在所有门诊护理中心和医院进行的癌症相关临床试验中，DLDCCC是一部分。CTSU 所有从事临床研究的DLDCCC成员都可以获得服务。的主要职能 CTSU将提供： 1.协助处理与临床研究和试验相关的监管和行政事务，包括机构审查委员会 合规性和批准、持续的修订和更新、外部机构合规性（例如 FDA），以及监管文件的维护， 2.临床试验信息学专业知识，特别是维护癌症相关临床试验的电子数据库 方案、患者登记和临床数据，以及监测和报告累积， 3.质量保证/质量控制稽查和人员培训，以确保研究团队得到培训 临床研究的最佳实践， 4.研究护理/临床试验管理。在最近的一年01/01/2018-12/31/2018，CTSU 支持了224项干预性试验，包括54项药物启动的研究，其中30项是在 IND和IDE下的3。 数据审查委员会和安全性监查委员会与临床试验的操作方面是分开的 由CTSU管理，其职能是确保参与者的安全，数据的有效性，以及适当的 在发现不适当的风险或似乎无法进行试验的情况下终止研究 成功进行。DLDCCC患者安全官员确保癌症中心的所有数据监测 试验是按照核准的监测计划进行的。 该委员会还监测应计费用，以确保妇女、少数民族、儿童、 和老年人进行临床研究。