Standards Implementation

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

• CDISC ADaM Implementation Guide
• CDISC ADaM OCCDS 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