Clinical Protocol and Data Management

摘要-临床方案和数据管理 DCI临床方案数据管理(CPDM)团队驻留在临床研究办公室(CRO) 为DCI成员提供全面的协议和数据管理服务，包括开发、 进行、数据管理、监测和报告与癌症相关的临床研究。CPDM的任务是 为集中化进程提供基础设施，以便促进、评估科学价值、 所有与癌症相关的临床方案的进展、质量保证、安全性和报告，以支持DCI提供 为我们所有受癌症影响的患者提供新颖和创新的治疗方法。 CPDM从概念上为DCI成员提供全面的临床研究方案服务 开发、法规提交、数据报告、协议监控和结案。这个集中式 该方法允许CRO主动评估临床试验组合、其性能、依从性 监管标准及其与DCI和机构优先事项的一致性。 DCI CRO为DCI领导提供全面的数据和指标，多学科疾病 小组、研究计划负责人和调查人员支持他们的运营和决策。CPDM 使协议审查和监控系统(PRMS)能够分析协议启动和批准时间 以找出审查过程中的差距，以提供持续的效率。CPDM还允许DCI遵守 联邦授权的ClinicalTrials.gov和NCI临床试验报告计划(CTRP)要求。这个 CPDM在符合21CFR Part 11标准的电子设备中促进临床试验数据库的设计和开发 数据捕获平台。 在过去的项目期间，CPDM扩大了技术的使用，以提高效力和效率。 DCI与医学院一起实施了一个电子监管平台(Complion)，即临床试验 管理系统(OnCore)、新的eIRB系统(IRIS)和DCI成员控制台，以收集共享 研究计划和跟踪成员出版物的资源利用情况。 CPDM的首要目标是确保我们所有的患者都能获得临床试验。特别努力是 为患者提供参与临床试验的机会，而不分性别/性别、种族、 种族、社会经济地位或年龄。在目前的5年资助期内，DCI招收了13,826名受试者 在临床研究方案方面，包括7413名干预试验受试者和540名儿科受试者。已注册 基于总应计利润的受试者包括7919名女性(57.3%)和2954名少数民族(21%)。还有一个 大力支持国家临床试验网络(NCTN)和UM1/ETCTN研究，包括 358名患者参加了成人NCTN治疗研究，319名患者参加了NCORP研究，279名患者参加了儿科研究 COG研究和过去5年UM1/ETCTN研究中累积的102名患者。

ABSTRACT – CLINICAL PROTOCOL AND DATA MANAGEMENT The DCI Clinical Protocol Data Management (CPDM) team resides in the Clinical Research Office (CRO) and provides comprehensive protocol and data management services to DCI members including development, conduct, data management, monitoring and reporting of cancer-related clinical research. The CPDM mission is to provide the infrastructure for centralized processes that allow the facilitation, assessment of the scientific merit, progress, QA, safety and reporting of all cancer-related clinical protocols to support the DCI’s mission of providing novel and innovative therapies to all of our patients affected by cancer. The CPDM provides comprehensive clinical research protocol services to DCI members from concept development, regulatory submission, data reporting, protocol monitoring, and close out. This centralized approach allows the CRO to proactively assess the clinical trials portfolio, its performance, compliance with regulatory standards, and its alignment with DCI and institutional priorities. The DCI CRO provides comprehensive data and metrics to the DCI leadership, multidisciplinary Disease Groups, Research Program leaders, and investigators to support their operations and decisions. The CPDM enables the Protocol Review and Monitoring System (PRMS) to analyze protocol startup and approval times in order to identify gaps in review process to provide ongoing efficiency. CPDM also permits the DCI to comply with federally mandated ClinicalTrials.gov and NCI Clinical Trials Reporting Program (CTRP) requirements. The CPDM facilitates design and development of clinical trial databases in a 21CFR Part 11 compliant electronic data capture platforms. During the past project period, the CPDM expanded the use of technology to facilitate efficacy and efficiency. With the School of Medicine, DCI implemented an electronic regulatory platform (Complion), Clinical Trials Management System (OnCore), a new eIRB system (iRIS) and a DCI membership console to collect shared resource utilization by research program and track member publications. The CPDM’s overarching goal is to ensure access to clinical trials for all of our patients. Special efforts are undertaken to provide the opportunity for patients to participate in clinical trials regardless of sex/gender, race, ethnicity, socioeconomic status, or age. During the current 5 year grant period, the DCI enrolled 13,826 subjects on clinical research protocols, including 7,413 subjects to interventional trials and 540 pediatric subjects. Enrolled subjects based on total accrual included 7,919 (57.3%) females and 2,954 (21%) minorities. There is also a substantial commitment to support of National Clinical Trials Network (NCTN) and UM1/ETCTN studies, with 358 patients accrued to adult NCTN treatment studies, 319 enrolled to NCORP studies, 279 enrolled to pediatric COG studies and 102 patients accrued to UM1/ETCTN studies over the past 5 years.