Overview

The SAS Clinical Standards Toolkit provides the following support for the CDISC ADaM 2.1 standard:
  • A metadata representation of the CDISC ADaM standard in a set of SAS data sets.
  • The ability to derive template (zero-observation) data sets for the ADaM subject-level Analysis (ADSL) data set, a representative Basic Data Structure (BDS) data set, and an analysis results data set.
    Note: Templates for additional ADaM data structures (such as ADAE) will be provided in future releases after the CDISC ADaM team approves them for use.
  • Implementation of version 1.1 of the CDISC ADaM Validation Checks as prepared by the CDISC ADaM team.
  • A sample reporting methodology that combines the analysis results metadata with a sample set of tables, listings, and figures (TLF) metadata to create example clinical study reports.