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Practical Methods for Creating CDISC SDTM Domain Data Sets from Existing Data

Creating CDISC SDTM domain data sets from existing clinical trial data can be a challenging task, particularly if the database was not designed with the SDTM standards in mind. A key step in the process involves determining which of the STDM domain datasets need to be produced for submission and then determining what conversion process will be necessary to produce them from the existing data. Adequate planning and documentation of the conversion process is an essential first step before programming begins. The basic component of the planning phase involves metadata mapping – determining how each of the variables in the existing data will relate to the variables contained in the SDTM domains to be produced. The documentation of the conversion process should be recorded in a format that facilitates efficient access by those involved in the planning, programming and validation phases of the conversion. Tools suited to the task of complex data mapping and data manipulation can significantly reduce cost and improve quality. This paper presents an example of a simple metadata mapping tool developed using SAS, Microsoft Excel and Visual Basic. The examples in this paper are based on the CDISC SDTM version 1.1, the SDTM Implementation Guide version 3.1.1 and SAS ® version 9.1.3.