Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10443648
• 负责人: JONATHAN C TRENT
• 金额: $ 22.2万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-10 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10443648
• 关键词: Address; Age; Black Populations; Bone Marrow Transplantation; Cancer Center Support Grant; Cancer Patient; Catchment Area; Child; Clinical; Clinical Data; Clinical Management; Clinical Protocols; Clinical Research; Clinical Trials; Comprehensive Cancer Center; Data; Development; Education; Enrollment; Ensure; Ethics; Ethnic Origin; Florida; Funding; Gender; Guidelines; Hispanic; Individual; Industry; Infrastructure; Institutional Policy; Intervention; Intervention Studies; Language; Location; Malignant Childhood Neoplasm; Malignant Neoplasms; Minority; Monitor; National Clinical Trials Network; Nursing Research; Operations Research; Patients; Pediatric Oncology Group; Peer Review; Policies; Process; Protocols documentation; Quality Control; Race; Regulation; Regulatory Affairs; Reporting; Research; Research Infrastructure; Research Personnel; Risk; Safety; Services; System; Time; Training; Translational Research; United States National Institutes of Health; Universities; Woman; Writing; anticancer research; base; data management; member; operation; patient safety; quality assurance; racial minority; recruit; research study; sexual identity

PROJECT SUMMARY: CLINICAL PROTOCOL AND DATA MANAGEMENT Part I: Clinical Protocol and Data Management (CPDM). The Sylvester Comprehensive Cancer Center (Sylvester) Clinical Research Services (CRS) provides Clinical Protocol and Data Management (CPDM) support for the conduct of cancer-related research studies at Sylvester, including the Downtown Miami Campus and four satellite locations. CRS comprises three units: 1) The Clinical Trials Coordination Unit (CTCU); 2) Research Committee Support Unit (RCSU); and 3) Quality Assurance Unit (QAU). The purpose of CRS is to provide a centralized, high quality infrastructure to support investigators with developing, implementing, and reporting on all Sylvester cancer research studies, with the safety of participating subjects as the highest priority. CRS assists with the activation and completion of clinical studies, accurately reports clinical study data, and ensures consistency and quality for all studies. The CTCU is comprised of Operations (Research Nurse support, data management, and study coordination) and Regulatory Affairs (regulatory support for timely initiation, compliance, and all protocol review and approval processes). The RCSU facilitates the administration of research committees. including the Protocol Review and Monitoring Committee and Data and Safety Monitoring Committee. The QAU ensures patient safety by providing quality assurance and training for CRS staff and monitoring compliance with Sylvester’s Data and Safety Monitoring Plan (DSMP) and all applicable policy and regulations. CRS supports National Clinical Trials Network, NCI-funded, peer-reviewed, investigator-initiated, and industry-sponsored studies. CRS uses the clinical trial management system Velos eResearch for patient and protocol registration and tracking requirements. In CY 2017, Sylvester CRS supported 1,518 interventional, 509 interventional treatment, and 3,050 non-interventional accruals. Part II: Data and Safety Monitoring (DSM). Sylvester’s DSMC performs risk-based monitoring to ensure the highest levels of patient safety for all Sylvester investigator-initiated studies. CRS provides effective quality control and education to Sylvester investigators and research staff to ensure compliance with the Sylvester DSMP. Part III: Inclusion of Women and Minorities. Sylvester has initiated and sustained many proactive efforts to promote recruitment of women and minorities into research. In CY 2017, enrollment to interventional studies comprised 45% women, 52% Hispanic, and 22% racial minorities, including Blacks and other individuals who self-identify as non-white. Part IV: Inclusion of Children. Sylvester supports the NIH policy and guidelines on the inclusion of children in research. As a member of the Children’s Oncology Group (COG) and the COG Pediatric Bone Marrow Transplant Consortium, Sylvester maintains a comprehensive clinical study portfolio for all pediatric cancers.

项目总结：临床方案和数据管理 第一部分：临床方案和数据管理（CPDM）。西尔维斯特综合癌症中心 （西尔维斯特）临床研究服务（CRS）提供临床方案和数据管理（CPDM） 支持在西尔维斯特开展癌症相关研究，包括迈阿密市中心 校园和四个卫星位置。CRS由三个部门组成：1）临床试验协调部门 （CTCU）; 2）研究委员会支助股（RCSU）;和3）质量保证股（QAU）。的目的 CRS将提供一个集中的、高质量的基础设施，以支持研究者开发， 实施和报告所有西尔维斯特癌症研究，以及参与受试者的安全性 作为最高优先级。CRS协助启动和完成临床研究，准确报告 临床研究数据，并确保所有研究的一致性和质量。反恐协调股由业务部门组成， （研究护士支持、数据管理和研究协调）和法规事务部（法规 支持及时启动、合规以及所有方案审查和批准流程）。RCSU促进 研究委员会的管理。包括议定书审查和监测委员会和数据中心 安全监察委员会。QAU通过提供质量保证和培训确保患者安全 CRS工作人员和监测遵守西尔维斯特的数据和安全监测计划（DSMP）和所有 适用的政策和法规。CRS支持国家临床试验网络，NCI资助，同行评审， 制药商发起和行业申办的研究。CRS使用临床试验管理系统Velos 针对患者和方案注册和跟踪要求的电子研究。2017年，西尔维斯特CRS 支持了1，518例介入性治疗、509例介入性治疗和3，050例非介入性应计费用。 第二部分：数据和安全监测（DSM）。西尔维斯特的DSMC执行基于风险的监控，以确保 所有西尔维斯特透析器启动的研究的最高水平的患者安全性。CRS提供有效的质量 对西尔维斯特研究者和研究人员进行控制和教育，以确保符合西尔维斯特 DSMP。 第三部分：妇女和少数群体的融入。西尔维斯特发起并持续了许多积极的努力， 促进招聘妇女和少数民族从事研究工作。2017年，干预性研究的入组人数 包括45%的妇女，52%的西班牙裔和22%的少数民族，包括黑人和其他个人， 自我认同为非白人。 第四部分：接纳儿童。西尔维斯特支持国家卫生研究院关于将儿童纳入 research.作为儿童肿瘤学小组（COG）和COG儿科骨髓的成员， 移植联盟，西尔维斯特保持一个全面的临床研究组合，为所有儿科癌症。