Plan

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

What belongs in Plan

• core trial design and schedule-of-activities work, including Design-owned cycle definitions and the read-only expanded Activities projection
• executable protocol decisions, conditions, outcomes, transitions, and events on the dedicated Decision logic page
• alternate and overlapping participant paths, periods, cycles, encounter groups, and reviewed scenarios on Participant journeys
• governed allocation plans, stages, factors, strata, populations, ratios, and triggers on Randomization
• 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.

Govern design identity

Every trial starts with one required primary design named Design 1. The Design page keeps Name, Characteristics, and Primary in its first Overview section, while Matrix owns the arm-by-epoch element assignments. Every design is visible as a tab, including when only one exists. Decision logic, Participant journeys, and Randomization display the selected design context instead of creating separate page-level names for design-owned sections.

Use Create design to add another governed design. Delete design replaces the former page-level reset action and is available only for a non-primary design; its governed history remains available. Promote another design before deleting the current primary.