CORE--CLINICAL PROTOCOL AND DATA MANAGEMENT

临床方案和数据管理共享资源（CPDMSR）由四个部分组成。主任协调资源的活动以及与研究人员和其他MCC组成部分（如PRMS、生物统计共享资源和MCC信息系统）的互动。中央方案办公室（CPO）协助研究者进行方案制定、申办者关系和法规事务，并促进通信、继续教育和信息系统开发。方案制定包括概念制定和方案起草、赠款和合同的制定以及研究企业的开展规划。赞助商关系包括维持赠款和合同。法规事务包括与有权进行方案操作的所有外部和内部组织的沟通。CPO发布“协议菜单卡”并维护MCC网站协议列表。CPO致力于使临床研究社区跟上不断变化的标准和要求，以进行临床研究。CPO与MCC的其他部门合作，开发和维护用于监测临床研究的数据库，并开发用于执行特定协议的数据库。以专业为导向的RN/CRA团队协助研究者管理受试者和数据。RN的使命是确保在高质量患者/受试者护理的背景下完成方案程序。CRA的使命是研究文件和不良事件报告。RN和CRA人员与MCC的其他部门合作，开发数据库，用于临床方案的实施和监测。监查委员会由医生、法规专家和数据管理专家组成。所有地方发起的方案都要接受监测委员会的访问。这些访视的目的是监测监管和方案依从性以及数据管理过程。

The Clinical Protocol and Data Management Shared Resource (CPDMSR) has four components. The Director coordinates the activities of the Resource and interactions with investigators and other MCC components such as PRMS, the Biostatistics Shared Resource, and MCC Information System. The Centralized Protocol Office (CPO) assists investigators with protocol development, sponsor relations, and regulatory affairs and facilitates communications, continuing education and development of information systems. Protocol development includes concept development and protocol drafting, development of grants and contracts, and planning for conduct of the research enterprise. Sponsor relations includes maintenance of grants and contracts. Regulatory affairs includes communication with all external and internal organizations with authority over protocol operations. CPO publishes a "protocol menu card" and maintains the MCC Website protocol list. CPO works to keep the clinical research community abreast of changing standards and requirements for the conduct of clinical research. CPO works with other MCC components to develop and maintain databases for monitoring clinical research as well as to develop databases for the conduct of specific protocols. Specialty-oriented RN/CRA teams assist investigators with the management of subjects and data. The RN mission is to assure that protocol procedures are accomplished within a context of high quality patient/subject care. The CRA mission is research documentation and adverse event reporting. RN and CRA personnel work with other MCC components to develop databases for the conduct and monitoring of clinical protocols. The Monitoring Committee consists of physicians, regulatory experts, and data management experts. All locally-initiated protocols are subject to Monitoring Committee visits. The purpose of these visits is to monitor regulatory and protocol compliance and data management processes.