Clinical Protocol and Data Management

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 (Sylvester)临床研究服务(CRS)提供临床方案和数据管理(CPDM) 支持在西尔维斯特进行与癌症有关的研究，包括迈阿密市中心 校园和四个卫星位置。CRS由三个单位组成：1)临床试验协调股 (2)研究委员会支助股(RCSU)；以及3)质量保证股(QAU)。目的 CRS将提供一个集中的、高质量的基础设施，以支持调查人员开发、 实施和报告所有西尔维斯特癌症研究，并确保参与对象的安全性 作为最高优先事项。CRS协助激活和完成临床研究，准确报告 临床研究数据，并确保所有研究的一致性和质量。CTCU由运营部门组成 (研究护士支持、数据管理和研究协调)和法规事务(法规 支持及时启动、合规以及所有协议审查和批准流程)。RCSU促进了 研究委员会的管理。包括议定书审查和监测委员会和数据 和安全监测委员会。QAU通过提供质量保证和培训来确保患者的安全 用于CRS工作人员，并监测Sylvester的数据和安全监控计划(DSMP)以及所有 适用的政策和法规。CRS支持国家临床试验网络，由NCI资助，同行审查， 由研究人员发起并由行业赞助的研究。CRS使用临床试验管理系统Velos 关于患者和方案登记和跟踪要求的电子研究。2017财年，西尔维斯特CRS 支持1518项介入治疗、509项介入治疗和3050项非介入应计项目。 第二部分：数据和安全监测(DSM)。Sylvester的DSMC执行基于风险的监控，以确保 为所有西尔维斯特研究人员发起的研究提供最高水平的患者安全。CRS提供有效的质量 对西尔维斯特调查人员和研究人员进行控制和教育，以确保遵守西尔维斯特 Dsmp。 第三部分：包容妇女和少数群体。西尔维斯特发起并持续了许多积极主动的努力 促进招募妇女和少数群体参与研究。2017财年，干预性研究招生 由45%的女性，52%的西班牙裔和22%的少数族裔组成，包括黑人和其他 自我认同为非白人。 第四部分：包容儿童。西尔维斯特支持美国国立卫生研究院关于将儿童纳入 研究。作为儿童肿瘤学小组(COG)和COG儿科骨髓小组的成员 移植联合会，西尔维斯特为所有儿科癌症维持全面的临床研究组合。

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.