Plan

Plan is the structured planning step for a trial. It covers the design and execution planning surfaces that guide how the study will run.

What belongs in Plan

• trial design and schedule-of-activities work, including Design-owned cycle definitions and the read-only expanded Activities projection
• recruitment, retention, and monitoring plans
• safety and statistical planning
• governed project workspaces that translate the trial plan into tasks, owners, dependencies, and risks

Project workspaces keep execution planning inside the governed form model. Tasks store forward dependencies, owner assignments, source grounding, status, priority, and dates. Risks are managed as connected plan records with a single severity level and status, while “blocks” views are derived from task dependencies instead of stored as a separate project concept.

Projects require a start date and accept an optional end date. When the end is omitted, the initial range uses the start date; generated tasks cannot begin before that boundary, dependent tasks follow their latest predecessor, and the project end expands to cover the latest scheduled task. The Gantt is a view of those persisted dates rather than a separate schedule.

Reset Trial Design

Reset All in the Design view is available only when authored design or cycle data exists. After confirmation, it clears the Design fields and cycle definitions and saves the empty design as a new governed version. Earlier content remains recoverable from Activity.