ADaM

Concept

SDTM and ADaM data sets are programmed according to the associated specifications, and validated against a  series of electronic integrity checks to ensure compliance to the models. Additional QC includes independent  verification of results.

More Info

In the Subject-Level Analysis Dataset (ADSL)  only one record is created for all subjects.

In the Basis Data Structures (BDs) one or more records per subject are generated per analysis parameter, per analysis time point (conditionally required).

The so called „Other” section of ADaM specifically contains – among others – the Basic Data Structure for Time-to-Event Analysis and Data Structure for Adverse Event Analysis.

TOP