Data Core

摘要 卡波西肉瘤(KS)抗逆转录病毒时代的数据管理和集成核心(DMIC) 非洲治疗计划(KEAAP)负责简化和协调数据管理， 分析程序、统计分析以及支持研究的生物标本存储和库存 KEAAP试点和研究项目提出的活动。DMIC将密切履行其职责 与行政核心和职业发展核心以及KEAAP调查人员合作，以 确保高效遵守协议并一致应用高质量控制、生物安全和数据 安全实践。DMIC将在实现KEAPP研究目标方面发挥关键作用，并支持 与KEAAP相关的其他资助项目和新举措，以及在培训 学生，研究员，和新的研究人员在这个艾滋病毒相关的恶性肿瘤计划。的目标是 DMIC将在坦桑尼亚和赞比亚发展先进的生物统计和流行病学能力 合作网站，通过共享和协调的数据收集系统，整合来自 三个伙伴机构现有的研究和临床信息学资源，以支持三个机构 提出研究项目和其他试点项目。这将通过完成三个目标来实现：1) 提供生物统计学和生物信息学解决方案、专业知识和支持服务，用于设计和实施 KEAAP在临床、实验室研究和实验领域的研究项目。2)创建 标准化的操作程序、数据库和数据收集工具，以确保质量标准 在整个为期5年的研究期间，所有KEAAP项目分支。3)为KEAAP提供支持和培训 财团。DMIC将与KEAAP调查人员合作设计、测试和实施在线数据 收集工具和研究数据库使用红帽™(研究电子数据捕获)来满足特定的 调查人员的需求。DMIC将执行所有统计分析，并与调查人员合作 准备演示文稿、手稿和进度报告。DMIC将培训和监督每个中心的人员 数据录入制度特别强调数据的完整性、安全性和保密性。其他内容 将举办讲习班，以增加能力，并在最先进的国家之间分享知识 数据管理、共享和软件方面的最新进展。DMIC的活动将促进分享 项目之间的研究成果和数据，增加研究人员之间的合作，并促进 制定新的研究建议，从而整合所获得的知识。

ABSTRACT The Data Management and Integration Core (DMIC) of the Kaposi Sarcoma (KS) in Era of Antiretroviral Therapy in Africa Program (KEAAP) is responsible for streamlining and coordinating data management, analytical procedures, statistical analysis, and bio-specimen storage and inventory in support of the research activities proposed by the KEAAP pilot and research projects. The DMIC will perform its responsibility in close collaboration with the Administrative Core and Career Developmental Core, and KEAAP investigators to ensure efficient protocol adherence and consistent application of high quality control, biosafety and data security practices. The DMIC will play a critical role in achieving KEAPP research objectives, and in supporting other funded projects and new initiatives thematically related to the KEAAP, as well as in the training of students, fellows, and new investigators within this HIV-associated malignancies program. The objective of DMIC is to develop advanced biostatistics and epidemiology capabilities at the Tanzania and Zambia partnering sites, through a shared and coordinated data collection system, with data integration from the existing research and clinical informatics resources at the three partner institutions to support the three proposed research project and other pilot projects. This will be achieved by the completion of three aims: 1) Provide biostatistics and bioinformatics solutions, expertise and support services for the design and conduct of KEAAP research projects in the areas of clinical, and laboratory studies and experiments. 2) Create standardized operating procedures, databases, and data collection tools to ensure quality standards throughout the 5-year study period for all KEAAP project arms. 3) Provide support and training to the KEAAP consortium. The DMIC will work with KEAAP investigators in designing, testing, and implementing online data collection tools and study databases using REDCap™ (Research Electronic Data Capture) to meet the specific needs of the investigators. The DMIC will perform all statistical analysis, and work with investigators in preparing presentations, manuscripts and progress reports. The DMIC will train and oversee personnel at each institution on data entry placing special emphasis on data integrity, security and confidentiality. Additional workshops will be conducted to increase capacity and shared knowledge across countries of the most up-to date advances in data management, sharing and software. Activities of the DMIC will facilitate the sharing of research findings and data among projects, increase collaborations between the researchers, and promote the development of new research proposals, thereby integrating the knowledge acquired.