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Build

How the Build step in TrialStack groups the assets and materials teams create around a trial.

Build is the asset-building step for a trial. It groups the working materials and reusable artifacts teams create to support execution and communication.

What belongs in Build

  • Analysis configuration and governed handoffs
  • governed trial documents
  • Forms connected to scheduled activities, with generation for missing Forms
  • Files for Trial Master File filing and readiness
  • trial amendments
  • persona-oriented materials and audience context
  • governed exports and conformance evidence
  • Simulation packages that generate deterministic synthetic SDTM and ADaM automation-test datasets with retained lineage

Reusable Forms are maintained as governed workspace records. Use Build > Forms to review trial acquisition and place exact Form versions on scheduled activities.

Use Build > Exports > Simulation package when a team needs source-locked synthetic SDTM and ADaM data for automation testing. TrialStack generates Dataset-JSON 1.1 files from an explicit seed and retains their lineage. External validators, XPORT v5 rendering, and automation-target acceptance remain separate; the export status does not imply that those gates passed.