Summary
This guide outlines the process for creating Study Data Tabulation Model (SDTM) datasets in accordance with the CDISC SDTM standard for regulatory submissions. It details the essential components of SDTM datasets, which include information about clinical study participants, such as demographics, treatments, and observations. The guide emphasizes the importance of the SDTM Implementation Guide (SDTMIG) as a resource for understanding SDTM specifications and metadata. It provides a step-by-step approach to mapping source datasets to SDTM domains, including determining which domains to create, comparing data to SDTM metadata, and performing data conversion. The guide also describes various mapping scenarios, such as direct carry forward, variable renaming, and data structure transposition, necessary for ensuring compliance with SDTM standards. Overall, the document serves as a practical resource for those involved in the creation and validation of SDTM datasets.
