Trial Design

Shape the trial structure

flowchart LR
    Trial[Trial] --> Design[Design module]
    Design --> Generate[Generate structured design]
    Generate --> Review[Review and save]
    Design --> Compare[Compare and restore]

Trial Design is where teams maintain the structured design state of the trial and keep that state reviewable over time.

Keep the design surface separate

The design module exists because structural design work deserves its own governed place instead of being diluted inside the broader trial record.

Use it when the structure changes

Use this workflow when the trial design itself is evolving and the team needs a reviewable record of those changes.

Generate and review the complete design

Design generation can propose arms, epochs, elements, assignments, schedule timelines, visits, activities, sampling profiles, and cycle definitions. TrialStack resolves generated relationship references to the unique governed records they identify, keeps activity definitions and their scheduled placements together, and preserves element-to-intervention, parent, visit, timeline, and sampling-profile links. Element intervention links must belong to the same trial. Ambiguous or out-of-trial relationships remain unresolved for review, and every required planned visit must have activity coverage before a generated schedule can be accepted.

When a proposed arm is saved under a governed identity, TrialStack remaps visit applicability to that persisted arm instead of retaining the temporary generated id. Generated findings, section markers, and source-run provenance travel with the same governed design snapshot so reopening the page does not detach the reviewed design from the run that produced it.

Review generated sections in the same form used for authored changes. Saving keeps the governed design, schedule, and activity relationships together instead of treating generated output as a separate document. Fields omitted by a generated patch do not erase schema-managed nested data; an explicit reviewed clear remains distinct from omission.

Section headers retain an AI Generated badge after the design is saved or reopened. Hover over the badge to review any field- or section-specific generation findings, including unsupported content and recommended follow-up, and use its run link to inspect the originating generation evidence.

Restore a governed version

Restoring from Activity recreates the captured design structure, including versioned arms and schedule linkage fields, and records the justification supplied during restore. The form refreshes to the restored server state so the visible baseline matches the new governed version.

Watch the downstream impact

Design updates can affect later trial modules, so teams should treat them as governed changes and use history or restore when a design decision is being revisited.