Use the Build Study page to create or edit the Study Details, CRFs, Event Definitions, Subject Group Classes, Rules, Sites, and Users. Follow this basic workflow to design or edit a Study:
- The Study must exist, having been created using the Administration module.
- Change the current Study to the Study you want to work on. You must work at the Study level; the Build Study features are not available at the Site level.
- Access the Build Study page by selecting Tasks > Build Study.
The Build Study page opens for the current Study, presenting a table of the main Tasks, with status information for each, and options to view details, create new elements, and edit the existing configuration.
- Set the Study Status, if needed:
- When you are creating the Study, set the Status to Design, then click the Save Status button.
- After you've created the Study and are making edits, set the Status to Available, then click the Save Status button.
For more information, see Status of Study.
- Add to or edit the Study configuration by clicking the appropriate icon for Tasks 1 to 5 in the table. For details, see the following sections:
- Create Study: Edit Details
- Create and Modify Case Report Forms (CRFs)
- Create and Modify Event Definitions
- Create and Modify Subject Group Classes
- Create and Modify Rules
When you begin to work on a Task, the Task's Status changes from Not Started to In Progress.
- When you have finished a Task, select the checkbox in the Mark Complete column, then click the Save button. The Task's Status changes from In Progress to Complete. Note that you can make changes to a Task, even when its Status is Complete.
- After Tasks 1 to 5 are marked complete, add or modify Sites.
- Add or modify Users.
- If you haven't already done so, set the Study Status to Available, and click the Save Status button.
- After the Status is Available, add Subjects to the Study and start collecting Study data.
Build Study Page After Completing Study Setup: