Clinical, Protocol and Data Management

临床、方案和数据管理

• 批准号: 10674569
• 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/10674569
• 关键词: Agreement; Ambulatory Care; Amendment; Award; Budgets; Cancer Center; Cancer Center Support Grant; Catchment Area; Child; Clinical; Clinical Data; Clinical Investigator; Clinical Management; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Support Unit; Comprehensive Cancer Center; Data; Databases; Disease; Elderly; Electronics; Ensure; Event; Hospitals; Human Resources; Individual; Informatics; Institutional Review Boards; Intervention Trial; Maintenance; Malignant Neoplasms; Mediation; Medicine; Minority; Monitor; Nurses; Nursing Research; 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; 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项目摘要 Dan L Duncan综合癌症中心的临床方案和数据管理部分 （DLDCCC）包括临床试验支持单元（CTSU）和数据审查和安全监控 委员会。 CTSU为行为提供中央管理，研究支持和监督功能 在所有门诊护理中心和DLDCCC一部分的与癌症有关的临床试验中。 CTSU 所有从事临床研究的DLDCCC成员都可以使用服务。主要功能 CTSU将提供： 1。与临床研究和试验有关的监管和行政事务的协助，包括IRB 合规性和批准，持续的修正案和续订外部机构合规性（例如 FDA）和监管文件的维护， 2。临床试验知识专业知识，特别是维持与癌症相关临床的电子数据库 方案，患者注册表和临床数据，以及监视和报告， 3。质量保证/质量控制审计和人员培训，以确保对研究团队进行培训 在临床研究中的最佳实践中 4。研究护士/临床试验管理。在近一年01/01/01/2018–12/31/2018，CTSU 支持的224次介入试验，包括54项研究者发起的研究，其中30项是在 IND和3下的IDE。 数据审查和安全监控委员会与临床试验的运营方面分开 由CTSU管理和功能，以确保参与者的安全，数据的有效性和适当的 终止研究的研究已经发现了无关风险，否则似乎不能进行试验 成功进行。 DLDCCC患者安全官员确保癌症中心的所有数据监视 试验是根据批准的监视计划进行的。 CPDM还监视准确性，以确保对妇女，少数民族，儿童， 和临床研究中的老年人。