Data Core

UT-H数据核心将为3个研究项目的研究设计、数据录入和管理提供支持， 中风登记处，开发的其他研究项目，以及统计分析。此外，UT-H Data Core将在UT-H卒中中心与华盛顿其他卒中中心之间的协作项目中提供支持 斯波特里亚斯。最后，UT-H数据核心将作为临床试验中中风受训人员的教育资源 方法论。我们的数据核心将由M.H.拉赫巴尔教授指导，他是生物统计、流行病学主任， 和研究设计(BERD)的UT-H临床和翻译科学中心(CCTS)的核心。他是一个 经验丰富的生物统计学家，在管理数据协调中心方面具有丰富的专业知识，用于国家研究 自闭症和国际临床试验。拉巴尔博士将监督米里亚姆·莫拉莱斯、里克·斯莱恩和 数据核心的其他成员。我们很幸运有医学博士安德森担任生物统计学主席唐纳德·贝里博士 顾问，以及我们UT-H医学院的贝叶斯生物统计学家约瑟夫·勒克博士承诺支持 我们的PPARy项目(SHRINC项目2)和我们数据核心中的团队。UT-H数据核心代表了一个集成的 德克萨斯大学医学院、德克萨斯大学的统计学家、程序员和临床医生组成的团队 德克萨斯临床与翻译科学中心、德克萨斯大学生物信息学学院和医学博士 安德森生物统计学系。该团队共同遵循临床研究的设计和方法， 简化数据输入和管理，监控和评估数据质量，并开发创新的解决方案 关于数据管理和试验设计 数据核心的具体目标包括统计和临床试验方法学支持、试验设计、数据 年中风受训人员的协调、数据管理、数据保证、质量控制、报告和教育 生物统计学。数据核心将提供以下功能： 1.临床研究设计和方法支持，用于规划、实施和分析协作 项目，中心的具体项目，并在开发新的研究假设，特别是多中心 急性中风治疗的试验。 2.在我们的网站上为临床医生和研究人员提供统计分析支持，并开发创新的研究设计 用于复杂试验设计的解决方案，鼓励跨SPOTRIAS站点协作，促进出版，以及 数据共享。 3.建立和监测数据收集、管理、处理、质量控制、数据保证、 安全、通信和文档。 4.维护中风小组看到的所有中风患者的登记，并将此数据传输到共享的 SPOTRIAS数据库。 5.为中风学员提供临床试验方法学和生物统计学方面的教育资源。 统计分析支持将包括协调试验设计和实施，包括生物统计学、流行病学、 药物、试验管理、数据库管理、研究表格设计、数据编辑、质量控制、安全性和 功效分析。数据核心将提供统计支助，以便利出版物的摘要和手稿 和演讲。此外，数据核心将继续为我们的中风开发教育组件 临床试验方法学和医学统计推理的实习生。此外，数据核心的教职员工将 有极好的机会实施进行临床试验和协调的方法改进 多点/多中心临床试验。数据收集和存储是对SQL Server 2005数据库的升级，具有 一个ASP.NET前端。我们会继续采取适当措施，确保有关资料的准确性和保密性。 数据。数据库设计和计算机程序开发按照公认的BEST进行 练习。 Data Core在此应用中提供的架构将确保我们的临床研究企业 SPOTRIAS网站将保持我们在研究开发、行为和报告方面的高标准，同时 在我们与其他中心合作并培训新员工的过程中，保持我们持续增长所需的灵活性 翻译研究中的调查人员..

The UT-H Data Core will provide support with research design, data entry and management of 3 Research Projects, the Stroke Registry, additional Research Projects as they are developed, and statistical analyses. In addition, the UT-H Data Core will provide support in collaborative projects between the UT-H Stroke Center and other Stroke Centers in SPOTRIAS. Finally, the UT-H Data Core will serve as an educational resource for stroke trainees in clinical trial methodology. Our Data Core will be directed by Professor M. H. Rahbar, Director of the Biostatistics, Epidemiology, and Research Design (BERD) Core of the UT-H Center for Clinical and Translational Sciences (CCTS). He is an experienced biostatistician with significant expertise in managing data coordinating centers for a national study of autism and international clinical trials. Dr. Rahbar will oversee the work conducted by Miriam Morales, Rick Sline and other members of Data Core. We are fortunate to have Dr. Donald Berry, MD Anderson Chair of Biostatistics as a consultant, and a commitment from Dr. Joseph Lucke, Bayesian Biostatistician at our UT-H Medical School to support our PPARy Project (SHRINC Project 2) and the team in our Data Core. The UT-H Data Core represents an integrated team of statisticians, programmers, and clinicians across The University of Texas Medical School, The University of Texas Center for Clinical and Translational Sciences, The University of Texas School of Bioinformatics, and MD Anderson Department of Biostatistics. The team works together to follow clinical research design and methodology, streamline data entry and management, monitor and evaluate data quality, and to develop innovative solutions regarding data management and trial design The specific aims of the Data Core encompass statistical and clinical trial methodological support, trial design, data coordination, data management, data assurance, quality control, reporting, and education of stroke trainees in biostatistics. The Data Core will provide the following: 1. Clinical research design and methodological support in the planning, conduct, and analysis of collaborative projects, center specific projects, and in the development of new research hypotheses, in particular multicenter trials of acute stroke therapy. 2. Statistical analysis support for clinicians and researchers at our site as well as develop innovative study design solutions for complex trial designs, encourage collaboration across SPOTRIAS sites, facilitate publications, and data sharing. 3. Establish and monitor systems for data collection, management, processing, quality control, data assurance, security, communication, and documentation. 4. Maintain a registry on all stroke patients seen by the Stroke Team, and transmit this data to the shared SPOTRIAS database. 5. Serve as an educational resource for stroke trainees in clinical trial methodology and biostatistics. Statistical analyses support will include concordant trial design and conduct including biostatistics, epidemiology, medicine, trial management, database management, study forms design, data editing, quality control, safety and efficacy analyses. The data core will provide statistical support to facilitate abstracts and manuscripts for publications and presentations. In addition, the data core will continue to develop our educational component for our stroke trainees in clinical trial methodology and statistical reasoning in medicine. Furthermore, the faculty in the Data Core will have an excellent opportunity to implement methodological improvements for conducting clinical trials and coordinating multisite/multicenter clinical trials. The data collection and storage is an upgrade to a SQL Server 2005 database with an ASP. NET front end. Appropriate measures will continue to be used to insure the accuracy and confidentially of the data. Database design and computer program development are conducted in accordance with accepted best practices. The structure provided by the Data Core in this application will ensure that the clinical research enterprise of our SPOTRIAS site will maintain our high standards in research development, conduct and reporting, while at the same time maintain the flexibility necessary for our continued growth as we collaborate with other centers and train new investigators in translational research..