Standards for creating analysis ready datasets are based on guidelines published by CDISC.  SCiAN develops the specifications for ADaM datasets based on the statistical analysis plan and the table, listing and figure shells.  The source data for the ADaM datasets are preferably the SDTM datasets but can also be done from the raw (native) study datasets.

SCiAN utilizes industry standards/references when creating ADaM datasets:

  • CDISC ADaM Implementation Guide
  • ADaM Controlled Terminology
  • Indication-specific ADaM domain specifications, if applicable

Our processes in ADaM development are as follows:

  • Map relevant raw or SDTM data variables to ADaM domains
  • Determine derived variables for analysis
  • Determine analysis flags (population, sub-group, criterion-based) needed for analysis
  • Create ADaM specification documents based on the above
  • Program ADaM domains
  • Validate ADaM domains
  • Create Define.xml
  • Create Study Reviewer’s Guide
  • Produce Submission Package
  • Quality Control at each step of the process