Course Description
The SDTM Advanced Topics training explores topics beyond SDTM Theory and Application, including complex SDTM modeling. Course topics are drawn from real-world examples identified through the standard development process as well as by the CDISC user community and our expert SDTM instructors.
Topics include the following: Timing Variables, Advanced Controlled Terminology Implementation, Findings About and Outcomes of OCCUR, The EX and EC Domains, Changes in Severities, Linking Data, Conformance Rules and Requirements, Associated Persons, Biospecimen Events, Lab-related data, --CAT & --SCAT Variables, Drug Classes, The 'Collected Summary Result Type' Variable
Prerequisites
- A working-level understanding of clinical research
- Practical implementation experience with SDTM standards (at least one year experience is recommended)