If a study plan has not yet been initiated by either your site or the sponsor, you can create the initial draft from the Study Plan tab in the main menu.
Create a New or Edit a Draft Study Plan
To create or edit a plan, complete the steps below.
- Select the study from the Study Selector.
- Select Study Plan.
- If no plan exists, click + Create to create a new plan. This will generate a new study plan in Draft status, populated with standard operational milestones. Some data may be automatically populated based on your sponsor or CRO’s Clinical Vault.
- Enter counts and dates in open fields. Hover over field names for descriptions.
- Select Send for Review: Select this to send to the sponsor or CRO for review.