Therapeutic Area Data Standard for Treatment of HIV

项目概要：艾滋病治疗领域数据标准 FDA CDER数据标准战略要求制定、实施和 维持全面的临床数据标准，以促进有效率和有成效的 审查监管申报资料。 根据FDA药物评价和研究中心（CDER）的需求声明， 进一步标准化研究数据术语和概念，用于疗效分析， 疾病和治疗领域（TA）的优先列表， 根据需要，该项目有三个具体目标： 1)临床数据交换标准联盟（CDISC）研究数据的开发 列表模型（SDTM）艾滋病毒治疗用户指南。本用户指南将提供 艾滋病毒数据提交的共同语言，并涵盖艾滋病毒特异性 医学概念。本用户指南将使用CDISC TA标准进行开发 发展过程，并将作为文件出版，供所有人查阅 使用和实施CDISC数据标准提交给 FDA. 2)制定实施所需的CDISC控制术语， CDISC SDTM数据标准在HIV治疗中的应用。 3)制定并向FDA提交TA规范，以协助FDA 评估数据标准中哪些SDTM内容可以纳入FDA 研究数据技术参考指南（TCG）。TA规范描述在 TA标准中使用的域和变量如何与不同 FDA认可的SDTM实施指南（SDTMEDICAL）版本。目标1）和2） 是制定治疗以下疾病的TA规范所需的必要科学内容 艾滋病。

Project Summary: Therapeutic Area Data Standard for Treatment of HIV The FDA CDER Data Standards Strategy calls for the development, implementation, and maintenance of comprehensive clinical data standards to facilitate the efficient and effective review of regulatory submissions. In response to the FDA's Center for Drug Evaluation and Research (CDER) statement of need to further standardize study data terminologies and concepts for efficacy analysis, and their prioritized list of disease and therapeutic areas (TAs) for which additional data standardization is needed, this project has three specific aims: 1) Development of a Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) User Guide for Treatment of HIV. This User Guide will provide a common language for HIV data submissions and cover representation of HIV-specific medical concepts. This User Guide will be developed using the CDISC TA Standards Development Process, and will be published as a document available to all organizations that use and implement CDISC data standards for submissions to the FDA. 2) Development of CDISC-Controlled Terminology needed for the implementation and application of CDISC SDTM data standards for Treatment of HIV. 3) Development and submission to the FDA of a TA specification to assist the FDA in assessing which SDTM content from the data standard can be included in the FDA Study Data Technical Conformance Guide (TCG). TA specifications describe in a succinct manner how domains and variables used in the TA standard relate to different versions of the FDA-recognized SDTM Implementation Guide (SDTMIG). Aims 1) and 2) are necessary scientific content needed to develop the TA specification for treatment of HIV.