Chapter 8: SDTM Validation

SAS Clinical Standards Toolkit

SAS Clinical Standards Toolkit Setup

SAS Clinical Standards Toolkit Validation Program

SAS Clinical Data Integration

OpenCDISC Validator

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

Chapter Summary

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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