Detailed Explanation
The Study Data Tabulation Model provides the fundamental standard for organizing and formatting clinical trial data for regulatory submission, specifying how raw data from clinical trials should be structured to facilitate regulatory review and analysis. SDTM defines a series of domain models that correspond to different types of observations collected in trials, including demographics, adverse events, concomitant medications, laboratory results, vital signs, and efficacy assessments. Each domain has defined variables with standardized names, labels, and formats, ensuring consistency across studies and sponsors.
The SDTM framework organizes domains into classes based on the type of observation they represent. Interventions domains capture information about treatments administered, including exposure to the study drug and concomitant medications. Events domains document discrete occurrences such as adverse events and protocol deviations. Findings domains contain quantitative or qualitative results from planned evaluations like laboratory tests, vital signs, and efficacy assessments. Special purpose domains address specific data types such as demographics, comments, and subject elements. This classification provides a logical structure that facilitates consistent data organization.