Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10190868
• 负责人: JONATHAN C TRENT
• 金额: $ 21.55万
• 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/10190868
• 关键词: Address; Age; 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; Hispanics; 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.

项目摘要：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（包括迈阿密市中心）进行癌症相关研究 校园和四个卫星地点。 CRS 包括三个单位： 1) 临床试验协调单位 （CTCU）； 2）研究委员会支持单位（RCSU）； 3) 质量保证部门（QAU）。目的 CRS 旨在提供一个集中的、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，确保参与受试者的安全 作为最高优先级。 CRS协助临床研究的启动和完成，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）和监管事务（监管 支持及时启动、合规以及所有协议审查和批准流程）。 RCSU 促进 研究委员会的管理。包括方案审查和监测委员会和数据 和安全监察委员会。 QAU 通过提供质量保证和培训来确保患者安全 针对 CRS 工作人员并监控西尔维斯特数据和安全监控计划 (DSMP) 的遵守情况以及所有 适用的政策和法规。 CRS 支持国家临床试验网络、NCI 资助、经过同行评审、 由研究者发起和行业赞助的研究。 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，Sylvester CRS 支持 1,518 例介入治疗、509 例介入治疗和 3,050 例非介入治疗。 第二部分：数据和安全监控 (DSM)。 Sylvester 的 DSMC 执行基于风险的监控，以确保 所有西尔维斯特研究者发起的研究中患者安全水平最高。 CRS提供有效的质量 对西尔维斯特调查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：妇女和少数群体的包容性。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族裔参与研究。 2017 年介入研究入学人数 其中 45% 为女性、52% 为西班牙裔、22% 为少数族裔，包括黑人和其他 自我认同为非白人。 第四部分：儿童的包容性。西尔维斯特支持 NIH 关于将儿童纳入其中的政策和指导方针 研究。作为儿童肿瘤学组 (COG) 和 COG 儿科骨髓组的成员 西尔维斯特移植联盟 (Transplant Consortium) 维护着针对所有儿科癌症的全面临床研究组合。