Clinical Protocol and Data Management

临床方案和数据管理

基本信息

批准号：
9789592
负责人：
JONATHAN C TRENT
金额：
$ 20.32万
依托单位：
UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-07-10 至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/9789592
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

项目摘要

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：临床协议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（Sylvester）进行与癌症相关的研究的支持，包括迈阿密市中心校园和四个卫星位置。 CRS包括三个单元：1）临床试验配位单元（CTCU）; 2）研究委员会支持部门（RCSU）； 3）质量保证单位（QAU）。目的 CRS将提供一个集中式的高质量基础设施，以支持研究人员的发展，通过参与学科的安全性实施和报告所有Sylvester癌症研究作为最高优先级。 CRS协助激活和完成临床研究，准确地报告临床研究数据，并确保所有研究的一致性和质量。 CTCU已完成操作（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，合规性以及所有协议审查和批准过程）。 RCSU的最爱研究委员会的管理。包括协议审查和监测委员会以及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对于CRS员工以及对Sylvester的数据和安全监控计划（DSMP）的监视遵守适用的政策和法规。 CRS支持国家临床试验网络，NCI资助，经过同行评审，研究人员发起的和行业赞助的研究。 CRS使用临床试验管理系统Velos 研究患者和协议注册和跟踪要求。在CY 2017，Sylvester CRS 支持1,518次介入，509次介入治疗和3,050个非惯例。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Sylvester研究者发起的研究的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的控制和教育，以确保遵守西尔维斯特 DSMP。第三部分：包括妇女和少数民族。西尔维斯特（Sylvester）发起并持续了许多积极的努力促进妇女和少数民族的招募研究。在2017年CY，介入研究的入学人数 45％的女性，52％的西班牙裔和22％的少数族裔，包括黑人和其他人自我识别为非白人。第四部分：包括儿童。 Sylvester支持NIH政策和有关将儿童纳入其中的准则研究。作为儿童肿瘤学组（COG）和COG小儿骨髓的成员西尔维斯特（Sylvester）移植财团为所有儿科取消者维持全面的临床研究组合。