Full course description
This course offeres an in-depth review of the SDTM General Observation Class(Interventions, Events, and Findings) as they relate to the targeted domains. For each specific general observation class complex modeling examples will be studied. This course provides a broad understanding of the challenges in modeling clinical trial data when implementing the SDTM standards. In addition this course wil provide an overview of the define.xml v2.0 component of SDTM, it's supplements, the Reviewer's Guide, and SDTM validation.