The ADaMIG specifies ADaM standard dataset structures and variables, including naming
conventions. It also specifies standard solutions to implementation issues.
The Analysis Data Model supports efficient generation, replication, and review of analysis results.
The ADaM syllabus includes ADaM standard data structures:
- Subject-Level Analysis Dataset (ADSL)
The ADSL dataset contains one record per subject. It contains variables such as subject-level population flags, planned and actual treatment variables for each period, demographic information, stratification and subgrouping variables, important dates, etc.
- Occurrence Data Structure (OCCDS)
ADaM OCCDS includes several examples with displays, data, and associated metadata applied to adverse events, concomitant medications, and medical history.
- Basic Data Structure (BDS).
A BDS dataset contains one or more records per subject, per analysis parameter, per analysis timepoint. Analysis timepoint is not required; it is dependent on the analysis. In situations where there is no analysis timepoint, the structure is one or more records per subject per analysis parameter. This structure contains a central set of variables that represent the actual data being analyzed. The BDS supports parametric and nonparametric analyses such as analysis of variance (ANOVA), analysis of covariance (ANCOVA), categorical analysis, logistic regression, Cochran-Mantel-Haenszel, Wilcoxon rank-sum, time-to-event analysis, etc.