AppalTRuST Biostatistics and Informatics Core

摘要--生物统计学与信息学核心 生物统计和信息学核心(BIC)将作为AppalTRuST研究设计和所有数据的枢纽- 相关活动，包括数据收集、联系、统一、分析、共享和安全。核心将会 包括生物统计和信息学专家以及具有开发调查、管理 和分析数据，并确保持续的数据安全。利用通过以下方式提供的技术资源 英国马基癌症中心，BIC将拥有所需的所有生物统计和信息学资源和专业知识 支持AppalTRuST项目，满足未来TCORS优先事项带来的额外需求。 BIC目标包括：(1)支持统计规划和分析、数据收集和数据协调需求 AppalTRuST项目和核心；(2)与社区外联和参与者合作 参与(COPE)核心，以开发跨项目和数据统一的数据收集工具 收集时间表；(3)创建安全、标准化和集成的AppalTRuST数据仓库；以及(4) 提供易于使用的工具，以确保利益相关者能够访问AppalTRuST数据仓库和其他中心 信息。 BIC将监督和协调研究设计的所有方面，以及数据收集、协调和 对所有项目和试点项目的分析。数据文件，包括结构化、半结构化和非结构化数据， 与数据词典和其他文档一起，将针对项目、试点和核心进行集中管理 在BIC。为了促进推论统计分析的概括性，BIC还将制定调查权重 适用于招募到AppalTRuST队列的所有参与者。在与COPE的合作下，BIC将协助每个项目 并试点协调开发数据收集工具，以支持无缝数据共享， 限制注册了多个项目的参与者的响应负担，并在整个过程中促进协同 中心。 BIC还将部署信息门户和报告机制，以使数据可广泛访问 利益相关者，用户只能访问他们被授权访问的数据，与他们的 需要。信息门户将包括仪表板以及分析和查询工具，这些工具可以定制 以与所需的利益相关者数据访问级别保持一致。最先进的分析方法和 信息科学将支持并渗透AppalTRuST内的所有项目、试点和核心，以确保 TCORS成功地实现了其在阿巴拉契亚肯塔基州调查FDA CTP监管优先事项的目标 通过协作、教育和开创性的监管科学研究。

ABSTRACT – BIOSTATISTICS AND INFORMATICS CORE The Biostatistics and Informatics Core (BIC) will serve as the AppalTRuST hub for study design and all data- related activities, including data collection, linkage, harmonization, analysis, sharing, and security. The core will include biostatistics and informatics experts and staff with extensive experience developing surveys, managing and analyzing data, and ensuring ongoing data security. Leveraging technology resources available through UK Markey Cancer Center, BIC will house all the biostatistical and informatics resources and expertise needed to support AppalTRuST projects and respond to additional needs arising from future TCORS priorities. BIC Aims include: (1) support the statistical planning and analysis, data collection, and data coordination needs of the AppalTRuST projects and cores; (2) collaborate with the Community Outreach & Participant Engagement (COPE) Core to develop data collection instruments harmonized across projects and data collection timelines; (3) create a secure, standardized, and integrated AppalTRuST Data Warehouse; and (4) Provide easy-to-use tools to ensure stakeholder access to the AppalTRuST Data Warehouse and other Center information. BIC will oversee and coordinate all aspects of research design as well as data collection, harmonization, and analyses for all projects and pilots. Data files, including structured, semi-structured, and unstructured data, along with data dictionaries and other documentation, will be managed centrally for projects, pilots, and cores in BIC. To facilitate the generalizability of inferential statistical analyses, BIC will also develop survey weights for all participants recruited to the AppalTRuST cohort. In collaboration with COPE, BIC will assist each project and pilot with coordinated development of data collection instruments to support seamless data sharing, limiting response burden for participants enrolled in more than one project and promoting synergy throughout the Center. BIC will also deploy informatics portals and reporting mechanisms to make data widely accessible to stakeholders, with users able to access only the data they have been authorized for, commensurate with their needs. The informatics portal will include dashboards, and analytical and query tools, which can be customized to coincide with the level of stakeholder data access needed. State-of-the-art analytical methods and information science will support and permeate all projects, pilots, and cores within AppalTRuST to ensure that the TCORS successfully meets its goal of investigating FDA CTP regulatory priorities in Appalachian Kentucky through collaboration, education, and pioneering regulatory science research.