Summary
This guide provides an overview of the Study Data Tabulation Model (SDTM) domains and their structure, which is crucial for effective implementation. It begins by defining SDTM domains as collections of logically related observations that share a common topic, such as Medical History or Vital Signs, and explains their classification into five main classes. The guide details the general observation classes, which include datasets for interventions, events, and findings, outlining their roles in clinical trials. It also describes the variable roles within SDTM domains, categorizing them into identifiers, topics, timings, qualifiers, and rules. Furthermore, the guide emphasizes the importance of core variables, which are essential for compliance with the SDTM Implementation Guide (SDTMIG). It concludes by recommending familiarity with the SDTMIG to facilitate the mapping and conversion of data to SDTM, ensuring a smoother implementation process.
