SDTM in Action Module 10: ​Findings About Events or Interventions 

Description

This training elucidates non-standard variables and their representation within SDTM datasets, alongside detailing the process of custom domain creation. Non-standard variables are sponsor-defined data elements lacking a designated space in SDTM parent domains. The training covers the Supplemental Qualifier dataset structure, explaining how it is used to incorporate these variables. It also provides guidance on determining observation class, selecting custom domain codes, and ensuring correct variable order in custom domains.

Learning Outcomes

At the end of this module, learners will be able to:

• Recognize the different data collection scenarios where the FA Findings Class Specialization may be used
• Understand how the required --OBJ variable is used in the FA  and how --OBJ, along with --TESTCD, provides the topic of the observation in FA domains
• Understand the implications and difference between representing FA as a single dataset or splitting it into separate datasets using the “Splitting of Domains” rules

Language: English | Duration: 01:24:03 | CEUs: 0.1