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总结 临床研究支持 (CRS) 办公室是临床方案和数据的主要机制 联盟中的管理（CPDM）。 CRS有利于高效审查、批准和实施 整个联盟的癌症临床研究。 CRS 服务包括整个协议的协助 生命周期，包括方案开发、审查和批准流程导航、指导和 在监管事务、培训和教育、沟通、向 NCI CTRP 注册新试验方面提供支持， 临时人员配置、合作团体试验管理、质量控制和保证以及数据和安全 管理。 2013年，CRS支持了1168项研究，比2008年增加了29%，新治疗的23% 患者参加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、协议和同意书控制提交，并提供临床的其他关键方面 试验，它对联盟研究基础的影响异常强烈，所有研究者和研究 进行临床研究的团队在研究的整个过程中每天都使用其服务。 CRS工作人员 成员分为四个互动部门：研究实施支持、质量和合规性、 研究支持服务以及数据管理和报告。数据和安全监控涵盖所有 数据监控、验证数据有效性和完整性以及确保研究参与者的安全等方面 临床试验和临床试验根据风险程度、规模和复杂性进行监控。数据一起 安全监察委员会及其合规小组委员会确保研究者发起的试验得到遵守 根据所有规定的政策和程序进行，以保护人类的权利和福祉 科目。该联盟致力于增加少数族裔和儿童对临床的参与 通过继续与我们流域内的这些人群建立信任和接触来开展研究。新的 正在采取举措，尽量减少使用伙伴机构医疗保健服务的障碍，消除 资格、招聘或参与障碍，并找到鼓励参与和保留的方法 各类人群。