ADaM

TipWhat this section covers

This section presents ADaM-focused work including analysis dataset design, derivation traceability, validation/QC workflows, and submission-supporting documentation (including ADRG).

Overview

ADaM enables reproducible statistical analysis and direct support for TLF production. My ADaM approach emphasizes:

  • Analysis readiness aligned to SAP/planned analyses
  • Traceable derivations from SDTM to analysis variables
  • Clear population and endpoint definitions
  • QC and validation discipline
  • Submission-ready documentation and reviewer support

The focus is on building datasets that are scientifically useful, operationally reliable, and easy to audit.

What you’ll find in this section

ADaM Overview

  • ADaM strategy and analysis-use framing
  • Relationship to SAP/TLF planning
  • Traceability and reproducibility mindset

Domain Examples

  • ADSL
  • ADAE
  • ADVS
  • ADTTE
  • Example derivation and analysis-use considerations

Submission and Documentation Support

  • Submission package organization
  • Define metadata support
  • ADRG preparation and reviewer-oriented explanations

Build Quality, Programs, Validation, and QC

  • Program organization and derivation flow
  • Validation and consistency checks
  • QC approaches for datasets and analysis variables
  • Review and issue-resolution practices

Standards

  • ADaM standards alignment and implementation consistency
  • Practical standards interpretation across studies/endpoints

Representative ADaM contributions

  • Translate SAP analysis intent into reproducible analysis datasets
  • Build derivations with explicit traceability to source/SDTM inputs
  • Support QC and validation reviews with documented rationale
  • Prepare ADaM/ADRG deliverables for reviewer-friendly navigation

Working style

My ADaM workflow is analysis-driven and traceability-first:

  • Start from analysis questions and TLF needs
  • Define derivation logic clearly and consistently
  • Validate key variables and populations early
  • Package outputs and documentation for efficient review