SDTM

TipWhat this section covers

This section shows SDTM-focused work including domain construction, standards interpretation, validation/QC practices, and submission-supporting artifacts.

Overview

SDTM is the foundation for standardized clinical tabulation data and downstream traceability. My SDTM workflow emphasizes:

  • Standardized structure and metadata consistency
  • Protocol/CRF-to-domain traceability
  • Controlled terminology and variable role discipline
  • Validation and issue resolution readiness
  • Submission support (define/SDRG/CRF alignment)

The goal is to deliver SDTM packages that are not only valid, but also easy to review and maintain.

What you’ll find in this section

SDTM Overview

  • SDTM strategy and implementation approach
  • Domain planning and standards interpretation
  • Traceability principles and submission context

Domain Examples

  • DM
  • AE
  • VS
  • Example domain-level implementation and QC considerations

Submission and Documentation Support

  • Submission packaging considerations
  • CRF mapping support
  • Define metadata support
  • SDRG support and reviewer guidance

Build Quality, Programs, Validation, and QC

  • Build process organization
  • Programming workflow practices
  • Validation summaries and issue tracking approach
  • QC structure and repeatable checks

Standards

  • Versioning awareness
  • Standards interpretation practices
  • Consistency across domains and studies

Representative SDTM contributions

  • Build and review domain datasets with traceable source alignment
  • Support variable-level consistency checks and standards compliance
  • Organize validation findings and resolutions for efficient review
  • Prepare SDTM deliverables in a reviewer-friendly structure

Working style

My SDTM work is standards-first and review-aware:

  • Interpret standards carefully and document assumptions
  • Prioritize consistency across domains
  • Build QC into the workflow, not just at the end
  • Maintain clear submission-supporting documentation