CORE--PATIENT ACCESS AND DATA MANAGEMENT

核心——患者访问和数据管理

• 批准号: 5207276
• 负责人: RICHARD A LARSON
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/5207276
• 关键词: acute nonlymphocytic leukemia; biomedical facility; cancer registry /resource; data collection; human subject; leukemia; medical records; statistics /biometry

One of the special features of this program is that the four individual projects are absolutely dependent upon patient material, since the questions to be addressed arise from the variability of individual patient response (i.e., Why do some patients develop secondary cancers and others not?). In addition to patient enrollment, chart review, and data collection, we propose again to incorporate within the original Core A formal support for database coordination, statistical analyses, and computation. The entire program project and the individual projects require close and continuing statistical collaboration to insure appropriate study design, data management and retrieval, and subsequent analyses of results. In this way, any problems with the study design that may arise may be corrected, and interim analyses of data may be disseminated promptly among the project investigators. The Patient Access Core have the dual missions of data management and statistical analysis which are critical to the successful completion of the proposed investigations and necessary to support and link together the results that will come from the various laboratories. In order to provide an orderly access to patient material and to maintain records, we propose to continue our Core A component to manage these functions. Requests for specific clinical materials (blood or marrow cells, tumor tissues, or cell lines from specific patients) will be directed by each project P.I. to Core A of the Program. After collection, the clinical specimens will be logged in and transmitted to Core B for processing and delivery to the individual projects.

这个节目的一个特点是，四个人 项目完全取决于患者的材料，因为 个别患者的多样性引发了需要解决的问题 反应(即，为什么一些患者会患上继发性癌症，而另一些患者则会 不是？)。除了患者登记、图表审查和数据 集合，我们再次建议将其并入原来的核心A 正式支持数据库协调、统计分析和 计算。整个计划项目和单个项目 需要密切和持续的统计协作，以确保 适当的研究设计、数据管理和检索，以及后续 结果分析。通过这种方式，研究设计中的任何问题 可能出现的情况可能会得到纠正，对数据的中期分析可能会 在项目调查人员中迅速传播。患者访问权限 CORE具有数据管理和统计分析的双重使命 这些对成功完成拟议的 调查和必要的支持并将结果联系在一起 将来自各个实验室。 为了提供对患者材料的有序访问并保持 记录，我们建议继续使用我们的核心A组件来管理这些 功能。要求提供特定的临床材料(血液或骨髓 来自特定患者的细胞、肿瘤组织或细胞系)将被 由每个项目P.I.指导到计划的核心A。收集完毕后， 临床标本将被登录并传输到核心B以进行 加工并交付给各个项目。