In this talk, an introduction into CDISC, especially in SDTM and the strategy how to program it, were presented.
The talk started with general information and important terms about the fundamentals of SDTM. We discussed the different kinds of datasets and how variables can be classified. Furthermore, we talked about the use of the controlled terminology.
The second part of this talk was about programming of SDTM domains. Steps and tips how to create datasets, Trial design model datasets, sponsor defined domains, and the appropriate specification sheet, were presented. Finally, the QC with Pinnacle21 was discussed.