Clinical Protocol and Data Management

临床方案和数据管理 项目总结/摘要 Winship临床方案和数据管理（CPDM）部门为临床研究提供基础设施 在Winship进行。CPDM有三个主要目标：支持临床安全和道德行为 研究;促进高质量数据的生成;增加受试者获得临床试验的机会， 温希普集水区，重点是代表性不足的人口。CPDM包括Winship 临床试验办公室（CTO）、临床数据管理团队、法规专家、质量保证团队 (QAT)以及数据安全和监测委员会（DSMC）。CTO为所有人提供基础设施 试验实施的各个方面，包括设计、监管流程、激活、实施、数据收集和分析。 CTO还为Winship成员和工作人员提供临床研究方面的培训和教育。临床 数据管理团队和监管专家组成癌症疾病现场团队。团队 向各自疾病研究中心团队的医生负责人和CTO助理进行双重报告 董事们。首席技术官有一个专门的团队，专注于进行多机构试验，Winship 调查员作为PI。该小组协调试验的进行，并提供现场或远程监测， 参与机构。温希普试验投资组合有意分布在机构、行业- 申办、外部同行评审和NCI支持的国家临床试验网络（NCTN）试验。的 QAT协调员对机构和NCTN试验进行真实的审计，以确保合规性。DSMC负责监督 实施Winship数据安全和监控计划。DSMC的主要重点是确保 在机构、NCI资助和NCTN试验中的最高依从性水平。最近的趋势分析 可测量的输出显示Winship临床试验实施的关键指标有显著改善 包括试验入组、减少试验激活时间和遵守研究方案 要求.在目前的资助期间，Winship开发了新的研究相关标准 操作规程（SOP），改进CTO的人员配备，以满足临床试验增长的需求，以及 实施临床试验数据管理软件。一种用于生物样本跟踪的软件解决方案， 在本资助期内，已安装了放射反应评估软件系统。 在下一个资助期间，Winship将增加临床试验的患者应计费用，重点是 附属Winship设施，在这些地点发展更强大的临床研究基础设施，增加服务不足的 人口获得临床试验，增加Winship癌症网络内的临床试验访问，以及 改进临床试验信息平台。

CLINICAL PROTOCOL AND DATA MANAGEMENT PROJECT SUMMARY/ ABSTRACT The Winship Clinical Protocol and Data Management (CPDM) unit provides the infrastructure for clinical research conducted at Winship. CPDM has three main objectives: supporting the safe and ethical conduct of clinical research; promoting the generation of high quality data; and increasing access to clinical trials for subjects in the Winship catchment area, with an emphasis on underrepresented populations. CPDM includes the Winship Clinical Trials Office (CTO), clinical data management team, regulatory specialists, quality assurance team (QAT), and the Data Safety and Monitoring Committee (DSMC). The CTO provides the infrastructure for all aspects of trial conduct including design, regulatory processes, activation, conduct, data collection, and analysis. The CTO also provides training and education in clinical research for Winship members and staff. The clinical data management team and the regulatory specialists are organized in cancer disease site-based teams. Teams have dual reporting to the physician leaders of the respective disease site-based teams and to the CTO assistant directors. The CTO has a specialized team focused on the conduct of multi-institutional trials for which Winship investigators serve as PI's. This team coordinates trial conduct and provides on-site or remote monitoring of participating institutions. The Winship trial portfolio has an intentional distribution of institutional, industry- sponsored, externally peer-reviewed, and NCI-supported National Clinical Trials Network (NCTN) trials. The QAT coordinators audit institutional and NCTN trials in real time to ensure compliance. The DSMC oversees the implementation of the Winship data safety and monitoring plan. The primary focus of the DSMC is to ensure the highest level of compliance in the institutional, NCI-funded, and NCTN trials. Recent analyses of trends of measurable outputs reveal significant improvements in key measures of Winship clinical trial conduct including accrual to trials, reduced trial activation times, and compliance with study protocol requirements. During the present funding period, Winship has developed new research-related standard operating protocols (SOP), improved staffing of the CTO to meet the growth in clinical trials accrual, and implemented clinical trials data management software. A software solution for biospecimen tracking and another software system for radiologic response evaluation have been implemented during the current funding period. During the next funding period, Winship will increase patient accrual to clinical trials with an emphasis on the affiliated Winship facilities, develop stronger clinical research infrastructure at those sites, increase underserved populations' access to clinical trials, increase clinical trial access within the Winship Cancer Network, and improve clinical trials informatics platforms.