Evaluation of SDTM Data and Documentation

PharmaStat consultants evaluate the conformance and usability of SDTM data using OpenCDISC and a variety of other methods which catch additional issues. We review our findings with the Sponsor’s staff, identify significant diagnostics, and recommend corrective action.

An SDTM database is not fully qualified without its associated define.xml, Study Data Reviewer’s Guide and annotated CRF. Our define.xml validator checks technical conformance and also verifies the content of the define.xml against the database. It frequently identifies issues in the SDTM data that are missed by other validators.