Standards Implementation

SCiAN utilizes the following standards/references when creating ADaM datasets:

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

Our processes in SDTM 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
  • Quality Control at each step of the process