Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 9001923
• 负责人: PAUL J MARTIN
• 金额: $ 64.96万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-02-01 至 2019-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9001923
• 关键词: Adherence; Cancer Center Support Grant; Catchment Area; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Communication; Conduct Clinical Trials; Consent Forms; Data; Data Base Management; Data Collection; Data Reporting; Development; Eligibility Determination; Ensure; Forms Controls; Funding; Goals; Improve Access; Informatics; Institution; Life; Life Cycle Stages; Malignant Neoplasms; Minority Participation; Mission; Monitor; Monitoring Clinical Trials; Participant; Patients; Pilot Projects; Policies; Population; Procedures; Process; Protocols documentation; Quality Control; Recruitment Activity; Regulation; Regulatory Affairs; Reporting; Research; Research Personnel; Research Support; Review Committee; Rights; Risk; Safety; Safety Management; Services; Site; Social Welfare; Supervision; Therapeutic Clinical Trial; Training; Training Programs; Training and Education; Trust; Underserved Population; Woman; Work; base; cancer clinical trial; clinical investigation; data management; health care service utilization; health disparity; human subject; member; minority children; minority health; protocol development; quality assurance; safety study

CPDM Summary The Clinical Research Support (CRS) office serves as the principal mechanism for Clinical Protocol and Data Management (CPDM) in the Consortium. CRS facilitates the efficient review, approval, and implementation of cancer clinical research throughout the Consortium. CRS services include assistance throughout the protocol life cycle, including protocol development, navigation through review and approval processes, guidance and support in regulatory affairs, training and education, communications, registration of new trials with NCI CTRP, interim staffing, management of cooperative group trials, quality control and assurance, and data and safety management. In 2013, CRS supported 1168 studies, a 29% increase over 2008 and 23% of newly treated patients participated in a therapeutic clinical trial. Since CRS directly manages Consortium training, protocol submission through activation, protocol and consent form control, and provides other critical aspects of clinical trials, its impact to the Consortium's research base is exceptionally strong, and all investigators and study teams conducting clinical research use its services on an everyday basis through the life of a study. CRS staff members are organized into four interactive divisions: Study Implementation Support, Quality and Compliance, Study Support Services, and Data Management and Reporting. Data and safety monitoring encompasses all aspects of data monitoring, verifying data validity and integrity, and ensuring the safety of study participants in clinical trials and clinical trials are monitored based on degree of risk, size and complexity. Together, the Data Safety Monitoring Committee and its Compliance sub-committee ensure that investigator initiated trials are conducted according to all required policies and procedures in order to protect the rights and welfare of human subjects. The Consortium is committed to increasing the participation of minorities and children in clinical research by continuing to build trust and engagement with these populations in our catchment area. New initiatives are underway to minimize barriers to using the health care services of partner institutions, remove eligibility, recruitment or participation barriers, and find ways to encourage participation and retention for populations of all types.

CPDM摘要 临床研究支持(CRS)办公室是临床方案和数据的主要机制 财团中的管理层(CPDM)。CRS有助于高效地审查、批准和实施 整个联盟的癌症临床研究。CRS服务包括在整个协议中提供帮助 生命周期，包括制定议定书、通过审查和批准程序导航、指导和 在监管事务、培训和教育、通信、向NCI CTRP登记新试验方面提供支持， 临时人员配置、合作组试验管理、质量控制和保证以及数据和安全 管理层。2013年，CRS支持了1168项研究，比2008年增加了29%，在新治疗的研究中增加了23% 患者参与了一项治疗性临床试验。由于CRS直接管理联盟培训、协议 通过激活、方案和同意书控制提交，并提供临床的其他关键方面 试验，它对财团的研究基础的影响是异常强烈的，所有的调查人员和研究 进行临床研究的团队在研究的整个生命周期中每天都使用它的服务。CRS工作人员 成员被组织成四个互动部门：研究实施支持、质量和合规、 研究支持服务、数据管理和报告。数据和安全监控涵盖所有 数据监测，验证数据的有效性和完整性，并确保研究参与者的安全 临床试验和临床试验根据风险程度、规模和复杂性进行监测。总而言之，数据 安全监测委员会及其合规小组委员会确保调查员发起的试验 根据所有必要的政策和程序进行，以保护人权和福利 研究对象。该联盟致力于增加少数族裔和儿童在临床上的参与 通过继续在我们的集水区与这些人建立信任和接触来进行研究。新的 正在采取主动行动，尽量减少使用伙伴机构保健服务的障碍，删除 资格、招聘或参与障碍，并设法鼓励参与和留住 所有类型的种群。