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）团队位于临床研究办公室（CRO） 并为DCI成员提供全面的协议和数据管理服务，包括开发， 开展、数据管理、监测和报告癌症相关临床研究。CPDM的使命是 为集中化进程提供基础设施，以便利对科学价值的评估， 所有癌症相关临床方案的进展、质量保证、安全性和报告，以支持DCI的使命， 为我们所有的癌症患者提供新的和创新的疗法。 CPDM为DCI成员提供全面的临床研究方案服务， 开发、监管提交、数据报告、方案监测和关闭。本次集中 这种方法允许CRO主动评估临床试验组合、其绩效、 监管标准及其与DCI和机构优先事项的一致性。 DCI CRO为DCI领导层、多学科疾病管理机构和研究机构提供全面的数据和指标。 小组，研究项目负责人和调查人员，以支持他们的运作和决策。CPDM 使方案审查和监测系统（PRMS）能够分析方案启动和批准时间， 以便确定审查过程中的差距，以提供持续的效率。CPDM还允许DCI遵守 联邦政府授权的ClinicalTrials.gov和NCI临床试验报告计划（CTRP）要求。的 CPDM有助于在符合21 CFR第11部分的电子版中设计和开发临床试验数据库 数据采集平台。 在过去的项目期间，CPDM扩大了技术的使用，以提高效率和效率。 与医学院合作，DCI实施了电子监管平台（Complion），临床试验 管理系统（OnCore）、新的eIRB系统（iRIS）和DCI成员控制台， 研究计划和跟踪成员出版物的资源利用。 CPDM的首要目标是确保所有患者都能参与临床试验。特别努力 承诺为患者提供参与临床试验的机会，不分性别/性别、种族， 种族、社会经济地位或年龄。在当前的5年资助期内，DCI招募了13，826名受试者 临床研究方案，包括7，413例干预性试验受试者和540例儿科受试者。入组 基于总累积的受试者包括7 919名（57.3%）女性和2 954名（21%）少数民族。还有一个 大力支持国家临床试验网络（NCTN）和UM 1/ETCTN研究， 358例患者入组成人NCTN治疗研究，319例入组NCORP研究，279例入组儿童 COG研究和102例患者在过去5年中参加了UM 1/ETCTN研究。

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.