CDISC SDTM-ADaM Data Conversion Services

CDISC SDTM-ADaM Data Conversion Services

SDTM:

• SDTM programming is done using SAS 9.3
  • SDTM programming template
  • SDTM formatting work is highly automated (SUPP– generation,  variable ordering and labelling, ISO 8601 (partial) dates conversion, …)
  • Pinnacle21-Community (formerly OpenCDISC Validator is used to verify SDTM compliancy
• QC is done by comparing eCRF print-outs vs SDTM tables using dummy data to ensure different scenarios are covered
• External data integration/reconciliation + Dictionary coding integration handled via SAS as well (via odbc, or snapshot files)
• EPOCH, –BLFL: handled via study-specific algorithms

ADaM:

• Production of ADaM Datasets
  • Dataset specification file created (including metadata) using IDDI template
  • Programmed using latest SAS version, current ADaM Model and ADaM IG
  • CDISC compliance checked with Pinnacle-21 Community (formerly OpenCDISC Validator)

IDDI makes sure your data are ready for submission.