ADaM (Preview)

The Analysis Data Model (ADaM) defines standards for analysis-ready datasets.

Note

ADaM support is planned for a future release of Trial Submission Studio.

What is ADaM?

ADaM (Analysis Data Model) provides:

• Standards for analysis datasets
• Derived from SDTM data
• Ready for statistical analysis
• Required for FDA submissions

ADaM vs SDTM

ADaM Dataset Types

ADSL - Subject-Level Analysis Dataset

One record per subject containing:

• Demographics
• Treatment information
• Key baseline characteristics
• Analysis flags

BDS - Basic Data Structure

Vertical structure for:

• Laboratory data (ADLB)
• Vital signs (ADVS)
• Efficacy parameters

OCCDS - Occurrence Data Structure

For event data:

• Adverse events (ADAE)
• Concomitant medications (ADCM)

Other Structures

• Time-to-Event (ADTTE)
• Medical History (ADMH)

Planned Features

When ADaM support is added, Trial Submission Studio will provide:

ADaM Generation

• Derive ADSL from DM and other SDTM domains
• Create BDS datasets from SDTM findings
• Generate OCCDS from events domains

ADaM Validation

• Check ADaM IG compliance
• Validate traceability to SDTM
• Verify required variables

ADaM Export

• Export to XPT format
• Generate Define-XML for ADaM
• Include in submission package

Current Workarounds

Until ADaM support is available:

1. Export SDTM first

   • Use Trial Submission Studio for SDTM
   • Generate XPT files

2. Derive ADaM externally

   • Use SAS or R
   • Apply ADaM derivation rules
   • Generate analysis datasets

3. Validate separately

   • Use external validation tools
   • Check ADaM compliance

Timeline

ADaM support is on our roadmap. Priority features:

• ADSL generation
• BDS for VS and LB
• OCCDS for AE

Resources

CDISC ADaM Resources

• ADaM Implementation Guide
• ADaM Structure for Occurrence Data
• CDISC Library - ADaM

Stay Updated

• Check the Roadmap for updates
• Watch the GitHub repository for releases