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.

该计划的特色之一是四个人 项目绝对依赖于患者材料，因为 需要解决的问题来自于个体患者的差异 反应（即，为什么有些患者会发展为继发性癌症，而另一些患者会发展为继发性癌症） 不是？）。 除了患者登记、图表审查和数据之外 系列，我们再次建议将其纳入原始核心 A 中 对数据库协调、统计分析和 计算。 整个计划项目和个别项目 需要密切和持续的统计合作以确保 适当的研究设计、数据管理和检索以及后续 结果分析。 这样，研究设计中的任何问题 可能出现的情况可能会被纠正，并且可能会进行中期数据分析 并迅速在项目调查人员中传播。 患者访问 核心承担数据管理和统计分析的双重使命 这对于成功完成拟议的工作至关重要 调查以及支持和链接结果所必需的 将来自各个实验室。 为了有序地获取患者材料并保持 记录，我们建议继续使用核心 A 组件来管理这些 功能。 对特定临床材料（血液或骨髓）的要求 细胞、肿瘤组织或来自特定患者的细胞系）将被 由每个项目 P.I. 指导到该计划的核心 A。 收集后， 临床标本将被登录并传输至Core B 处理并交付给各个项目。