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
CDISC ADaM OCCDS 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