Chapter 8: SDTM Validation
SAS Clinical Standards Toolkit
SAS Clinical Standards Toolkit Setup
SAS Clinical Standards Toolkit Validation Program
Installing OpenCDISC Validator
Running OpenCDISC Validator (Graphical User Interface)
Evaluating the Report File and Report Results
Modifying the Configuration Files
Running OpenCDISC Validator in Command Line Mode
Because the title of this chapter is “SDTM Validation,” it might make sense to first clarify what is meant by the term validation. Two types of checks are important in this context: 1) ensuring that the data values are, in fact, what they should be and 2) ensuring that the dataset structures are what they should be. The latter ...
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