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Statistical

How the main trial record connects to statistical workflow in TrialStack.

Trials hold the governed trial record. Statistical is the workflow surface for statistical planning, reasoning, and review tied to that trial.

Analysis populations and cohorts

Statistical defines analysis populations such as intent-to-treat or safety populations. It does not define protocol cohorts.

When an analysis population applies to a cohort, select one of the trial cohorts authored in Plan > Recruitment > Population Segments. The stored relationship uses the Recruitment cohort ID while the form shows its readable label.

Trial Summary owns the forward relationships from each estimand to its endpoint, analysis population, intervention, intercurrent events, and sensitivity analyses. Statistical owns the referenced records and shows those relationships as derived context; it does not provide a second inverse authoring surface.

Why it matters

  • the team is managing statistical design or analysis context
  • statistical work needs to remain tied to the source trial
  • reviewers need trial context around statistical decisions

From each side