Clinical, Protocol and Data Management

临床、方案和数据管理

基本信息

批准号：
10025027
负责人：
HELEN E HESLOP
金额：
$ 30.26万
依托单位：
BAYLOR COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
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/10025027
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

项目摘要

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) 包括临床试验支持部门 (CTSU) 以及数据审查和安全监测部门 CTSU 为该行为提供中央管理、研究支持和监督职能。在属于 DLDCCC 的所有流动护理中心和医院开展与癌症相关的临床试验。 DLDCCC 从事临床研究的所有成员均可获得服务。 DLDCCC 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IRB 合规和批准、持续修订和更新、外部机构合规（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的电子数据库协议、患者登记和临床数据以及应计费用的监测和报告， 3. 质量保证/质量控制审核和人员培训，确保研究团队得到培训临床研究的最佳实践，以及 4. 研究护理/临床试验管理最近一年2018年1月1日至2018年12月31日，CTSU。支持 224 项干预试验，包括 54 项研究者发起的研究，其中 30 项是在 IDE下有IND和3。数据审查和安全监测委员会与临床试验的运营方面是分开的由 CTSU 管理，并负责确保参与者的安全、数据的有效性以及适当的如果发现不适当的风险，或者试验似乎无法进行，则终止研究 DLDCCC 患者安全官员确保癌症中心的所有数据监控顺利进行。试验是按照批准的监测计划进行的。 CPDM 还监督权责发生制，以确保妇女、少数民族、儿童、和老年人进行临床研究。