Development of Bipolar and Generalized Anxiety Disorder Standard Data Elements

双相情感障碍和广泛性焦虑症标准数据元素的开发

• 批准号: 8871620
• 负责人: Meredith Nahm Zozus
• 金额: $ 22.45万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-15 至 2016-08-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8871620
• 关键词: Development; Bipolar; Generalized; Anxiety; Disorder

Project Summary/Abstract The work proposed here will result in synthesized data elements for Bipolar and Generalized Anxiety Disorders, for use in human drug development and evaluation. Bipolar Disorder and Generalized Anxiety Disorder are two FDA priority areas for data standardization. The first aim of this work analyzes data collection forms (Case Report Forms (CRFs)) from new drugs approved since 2000 with an approved indication in Bipolar Disorder or Generalized Anxiety Disorder, to generate a master data element set that will support consistency in data collection by trial sponsors. The data elements will be vetted with clinical experts and harmonized with existing standards. The second aim of this work will be brought forward as a project in the HL7 Clinical Interoperability Council with the intent of balloting as an HL7 standard at the informative level. Ultimately, the data elements will be publically available through a public metadata registry. The team will annotate the data elements with mapping to existing terminology standards and to the CDISC SDTM, further increasing usefulness to the regulated industry of this resource. The third and final aim of this work explores rich terminologies relevant to regulatory decision-making in mental health, e.g., drug terminologies, structured document standards, e.g., structured product label, curated questionnaires, and an exploratory ontological representation of the Bipolar Disorder section of the Diagnostic and Statistical Manual of Mental Disorders, to identify links with standard data elements. Suck links will increase the types of questions that can be asked of data from regulatory submissions. !

项目概要/摘要 这里提出的工作将产生双相情感障碍和广泛性焦虑症的综合数据元素 疾病，用于人类药物开发和评估。双相情感障碍和广泛性焦虑 无序是 FDA 数据标准化的两个优先领域。这项工作的第一个目标是分析数据收集 2000 年以来批准的新药的表格（病例报告表 (CRF)） 双相情感障碍或广泛性焦虑症，生成支持的主数据元素集 试验申办者数据收集的一致性。数据元素将由临床专家进行审查 与现有标准一致。这项工作的第二个目标将作为一个项目提出 HL7 临床互操作性委员会旨在投票作为信息级别的 HL7 标准。 最终，数据元素将通过公共元数据注册表公开可用。团队将 通过映射到现有术语标准和 CDISC SDTM 来注释数据元素，进一步 增加该资源对受监管行业的有用性。这项工作的第三个也是最后一个目标探讨 与心理健康监管决策相关的丰富术语，例如药物术语、结构化术语 记录标准，例如结构化产品标签、策划问卷和探索性本体论 《精神疾病诊断和统计手册》中双相情感障碍部分的表述， 识别与标准数据元素的链接。吸吮链接会增加可以提出的问题类型 来自监管提交的数据。 ！