Validation of SDTM domains includes the following:

  • Random sample of subject data inspected and compared between the raw dataset and SDTM domain; SDTM specifications are also inspected
  • Checks by the SDTM programmer: log review, code review, requirements/specifications review, spot check review (ad hoc programming/visual checks on SDTM/raw data)
  • Programming of SDTM domains by an independent programmer: Independent programmer programs the SDTM domains per the requirements/specifications. The QC domains are compared with the main SDTM domains via PROC COMPARE
  • Pinnacle 21 or similar software: datasets are validated per CDISC and FDA validation rules

All findings are reviewed and resolved.