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SDTM 指研究数据制表模型（Study Data Tabulation Model）。它是制药和临床研究行业所需的标准化格式，用于组织人体临床试验中的患者数据并将其提交给监管机构，如美国食品药品管理局（FDA）。2004 年，SDTM 被宣布为临床研究数据提交的必备标准格式。根据 SDTM 结构证明数据可确保一致性，并使临床研究中的分析更高效、更透明。

SDTM 数据集，即研究数据制表模型数据集，是按照 SDTM 标准制作的数据表。SDTM is the required format for tabulation data submission to the FDA and PMDA. SDTM 数据集包含与临床试验患者有关的信息，包括人口统计学、治疗、不良反应等。Find out all you need to know about SDTM in our helpful blog >>

SDTM specifications describe how raw data is to be converted. 生物统计程序员使用它们将数据转换为 SDTM 格式。开发 SDTM 数据集的过程首先要从 CRFs 和原始数据中确定所需的 SDTM 域开始。然后，将原始数据集变量（Non-CDISC 结构）映射到相关的 CDISC SDTM 域变量。这样，您就能知道哪个原始数据集能为 SDTM 域提供数据。最后，列出每个 SDTM 领域的所有变量，并说明应如何对其进行编程。Want to know more? Read our helpful best practice guide to CDISC SDTM Mapping >>

SDTM mapping specifications describe how source data is transformed into SDTM datasets for regulatory submission. ADaM specifications define how SDTM data is further transformed into analysis-ready datasets which are used for statistical analyses, tables, listings, and figures (TLFs). Together, they provide traceability from collected data through to study results.

ADaM specifications define the structure, derivations, and metadata required to create analysis-ready datasets. Typically, teams begin by identifying analysis requirements, defining dataset structures and variables, documenting derivation logic, and establishing traceability back to source data and SDTM datasets. Using a specification management platform can help standardize this process, improve consistency, and reduce manual effort. Read our blog to learn 3 things you should know about ADaM standards

可以。Modern specification management platforms, like Pinnacle 21, can help teams create, manage, and reuse ADaM specifications while maintaining consistency, traceability, and version control. This reduces manual effort and accelerates the development of analysis-ready datasets.

If you’re new to Pinnacle 21 and want to get a feel for its basic validation capabilities, you can access Community here: https://help.pinnacle21.certara.net/en/articles/9736610-download-pinnacle-21-community