1

Applying CDISC © standards represents one of the major current challenge in the pharmaceutical industry community. Among the CDISC standards developed (and “stable”) so far, the SDTM is probably the most crucial since it has an immediate impact on how to submit data to the FDA in support of marketing applications (although this is not yet mandatory). Several approaches for and when implementing SDTM standards have been discussed in many public presentations (e.g. DIA, CDISC, PharmaSUG, PhUSE). After the first set of experiences and following the pilot CDISC/FDA project, we know at least that an organization is free to follow its own approach on how to implement SDTM; we can cite at least three approaches: build SDTM entirely in the Clinical Data Management System (pre); build SDTM entirely on the ‘back-end ’ (post); build SDTM using an hybrid approach (hybrid). Although the effort put by the CDISC developers in providing detailed guidelines (e.g. SDTM Model Implementation Guide Version 3.1.1) and examples, applying the proposed data-domain is not always an easy task, especially when you have to map data not supported by this standard (e.g. AE for adverse events, CM concomitant medications, VS vital signs, etc.). You may be in the position of solving one of the following issues: in which CDISC domain should I save my data? should I create a new ad-hoc domain? if I have to create a new ad-hoc domain, which ‘general class ’ should I use? if I have a variable not mapped to the standard domain I have selected, should I create a new variable or should I put it in the SUPPQUAL dataset? These are just examples of common issues we have encountered during the implementation of SDTM at SENDO we want to address and discuss in this paper. In particular we will focus the attention on the following aspects, by providing and discussing the solution we found: create an ad-hoc domain; map variables to SUPPQUAL datasets; define relationship. Furthermore we will make a quick report of problems encountered and the deviations we had to apply during our SDTM implementation