Create Study Reports
The Create Study Reports wizard enables you to add study report structures (folders and leaf elements) to an existing eCTD or CTD. You can run the wizard one or more times as you obtain information about the study reports to include in the assembly.
Note: The
Create Study Reports wizard does not support EAEU submissions.
The wizard is designed to be run after using the Create eCTD wizard, but you can use it any time after an eCTD is created. It enables you to do the following:
- Insert the appropriate study reports into an existing sequence or standalone assembly based on specification, template configuration, and user selections
- Insert a study report into an assembly structure with selected or confirmed metadata
Before creating a study report:
- An assembly must already exist and cannot be locked.
- The XML definitions must be applied for the assembly in the publishing settings.