Clinical Protocol and Data Management

项目总结：临床方案和数据管理 弗雷德和帕梅拉·巴菲特(BCC)临床试验办公室(CTO)，以前称为集中式 方案数据管理单位(CPDMU)，是支持临床癌症研究的中央办公室 癌症中心。BCC CTO为研究人员发起的试验(IIT)提供集中支持，NCI National 临床试验网络和合作小组试验(联盟主要成员，儿童肿瘤学小组，NRG) 多机构联合试验(BIG10癌症联合会，ACRU)和行业赞助的研究。这个 BCC首席技术官的任务是协助规划、开发、实施、质量保证、监测和 遵守监管机构对涉及癌症治疗和护理的临床试验的要求；以及 也为与癌症相关的人口科学研究提供监管支持。BCC首席技术官向 最高质量的研究，并通过研究的主要前期协调遵守相关法规 以及对研究合规性的持续审查。BCC CTO是癌症中心内的资源，它 为所有癌症临床研究的研究人员提供支持。它是由专注于疾病的团队(DFT)组织的 协调研究管理活动，包括筛选受试者；协调治疗和护理； 并收集和记录研究数据；以及负责提交 并维护所有监管文件和申请。BCC CTO为BCC调查人员提供支持 负责方案制定、数据管理、合作小组研究的监测以及与联邦 以及行业赞助商和监管机构。BCC CTO还为BCC Science提供支持 审查委员会(SRC)、数据安全监测委员会(DSMC)和审计委员会(AC)。 BCC CTO管理临床试验管理系统(OnCore)，该系统存储必要的方案数据 用于规划、报告和内部监督以及开发电子案件报告表(ECRF) 并研究Forte EDC(电子数据捕获)中的数据报告。BCC首席技术官一直积极参与NCI计划 关于临床试验报告计划(CTRP)。

PROJECT SUMMARY: CLINICAL PROTOCOL AND DATA MANAGEMENT The Fred & Pamela Buffett (BCC) Clinical Trials Office (CTO), previously referred to as the Centralized Protocol Data Management Unit (CPDMU), is the centralized office which supports clinical cancer research in the Cancer Center. The BCC CTO provides centralized support for investigator-initiated trials (IIT), NCI National Clinical Trials Network and cooperative group trials (Main Member of Alliance, Children's Oncology Group, NRG) multi-institutional consortium trials (BIG10 Cancer Consortium, ACCRU) and industry-sponsored studies. The mission of the BCC CTO is to assist with the planning, development, conduct, quality assurance, monitoring and compliance of with regulatory agency requirements for clinical trials involving cancer treatments and care, and to provide regulatory support for cancer-related population science studies as well. The BCC CTO assures the highest quality of research and adherence to relevant regulations by primary upfront coordination of the study and ongoing review of research compliance. The BCC CTO is the resource within the Cancer Center, which provides support to investigators for all cancer clinical research. It is organized by disease-focused teams (DFT's) that coordinate study management activities, including screening subjects; coordination of treatment and care; and collecting and recording study data; as well as the regulatory management teams responsible for submitting and maintaining all regulatory documents and applications. The BCC CTO provides BCC investigators support for protocol development, data management, monitoring for cooperative group studies, and liaison with federal and industry sponsors and regulatory bodies. The BCC CTO also provides support to the BCC Scientific Review Committee (SRC), the Data Safety Monitoring Committee (DSMC), and the Audit Committee (AC). The BCC CTO manages the clinical trials management system (OnCore) which houses protocol data necessary for planning, reporting and internal oversight, as well as the development of electronic case report forms (eCRF) and study data reporting in Forte EDC (Electronic Data Capture). The BCC CTO has been active in NCI initiatives regarding Clinical Trial Reporting Program (CTRP).