Trial Design

Trial design is where teams shape the operating structure of a trial and keep that structure aligned with the current study plan.

Who this is for

This page is for teams that maintain the planned structure of a trial and need a governed way to evolve it over time.

What this workflow covers

• maintaining the current design state
• validating that updates match the intended trial record
• reviewing design history over time

When to use the trial design workflow

Use this workflow when the team needs to update or review the structured design of a trial rather than its broader operational record.

Typical reasons include:

• the design structure has evolved
• the team needs a reviewable record of design changes
• later comparison or restoration may be needed

Typical workflow

1. Open the current trial design state.
2. Make the design updates needed for the current planning cycle.
3. Validate that the changes match the intended trial structure.
4. Review design history when the change is sensitive or disputed.
5. Restore a previous state when rollback is safer than editing forward.

flowchart TD
	A[Open current trial design state] --> B[Make design updates]
	B --> C[Validate against intended structure]
	C --> D[Review design history when needed]
	D --> E[Restore previous state if safer]

Key decisions

• who usually owns design updates
• which changes need explicit review
• how design history supports later audit and comparison workflows

Common mistakes to avoid

• treating design changes as disposable edits instead of governed updates
• changing design structure without checking how it affects downstream trial modules
• skipping history review when a design decision is being revisited

Related pages

• Trials
• Governance And Compliance

API reference

Use TrialStack API reference for exact design save, retrieval, and restore contract details.