Trial Statistical

Keep the analysis plan structured

flowchart LR
    Populations[Populations] --> Analysis[Statistical plan]
    Analysis --> Review[Review]

Trial Statistical is where teams maintain populations, methods, sample size assumptions, multiplicity handling, and interim analysis detail in a governed workflow.

Give the analysis model its own space

The statistical module exists because analysis planning is too important to bury in free text and too specialized to force into the generic trial overview alone.

Use it when the analysis logic evolves

Use this workflow when statistical assumptions or analysis structure need their own update and review path.

Keep the plan reviewable

The main value here is not only the latest answer. It is the ability to understand how the analysis plan changed and why.

When the statistical intent is ready to be translated into dataset metadata, continue in Analysis Specifications. Statistical remains the source of analysis intent; Analysis versions the downstream ADaM dataset, variable, derivation, and traceability specification without storing participant data.

When the plan is ready for delivery, open Exports and choose an electronic Statistical Analysis Plan (eSAP) format. TrialStack pins the exact Trial, Trial Statistical, and SAP Template versions, evaluates coverage, and renders JSON, XLSX, DOCX, or PDF from the same canonical specification and semantic checksum. Missing governed relationships appear as findings instead of invented content. A completed eSAP can also be saved as a draft SAP Document for the existing review and approval workflow.

Review collection changes

The Collection changes notice compares the trial’s current Form placements with the last recorded collection review. It checks for added or removed placements, selected Form or schedule changes, and newer reusable Form versions. A newer reusable version is a proposed placement upgrade; it does not change the version selected for the trial. Archived forms, scheduled activities, activity definitions, and visits are excluded from active collection sources. Activity-definition revisions are detected even when the selected form and placement are unchanged. The notice refreshes while the page is open.

Open Review collection changes to see the affected Form and visit, together with proposed review actions for collection timing, endpoint methods, and missing-data implications. These are automatically prepared review suggestions, not AI-authored Statistical edits. If no review has been recorded, the notice says so.

Make any necessary Statistical edits through the existing save review first. Then enter your review rationale and choose Record review. This creates an audited Statistical version containing the reviewed source snapshot and preserves the Statistical content. A changed source snapshot or Statistical version requires a fresh review. Ordinary manual saves and generation do not acknowledge collection changes automatically.