Empty Study Items that are unnecessary may be deleted by users with appropriate permissions. Study Items should only be deleted if they were created in error or are no longer relevant to the specific study. Study Items that are fulfilled (either with or without content, and even if not activated) cannot be deleted.
Tip: For study items that do not need to be present in the TMF that either need a permanent record or cannot be deleted, use the Mark as Fulfilled option. To remove a study item that has been fulfilled or finalized, use the “Virtual Delete” functionality.
Items that can be deleted:
- Documents marked as Core in the master list but not added to your study by a study, country, or site wizard.
- Documents that do not have the Is Core setting.
Items that cannot be deleted:
- Documents marked as Core in the master list and added to your study using the study, country, or site wizard. Note: These study items have an Is Core setting.
To delete a single study item:
- Go to the study item, click the Actions Menu icon, then select Delete Study Item.
2. In the Delete Study Item component window, select a Reason, enter additional Comments if necessary, and click Delete.
The study item will no longer appear in the TMF, and the action will be recorded in the audit trail.
Note: If you believe that a Study Item that should have a ‘Delete’ option does not have that option on its Actions menu, it could be because the Item had a Final document fulfilling it at one time.
To delete all study items:
- In the Study Items List page, select the actions menu and select Delete All. Note: If there are more than 50 items on the Study Items List page you will be alerted that you can only delete a maximum of 50 items at a time.
- In the Delete All Items window, select a Reason.
- Enter a Comment.
- (Optional) Deselect any items you do not wish to be deleted.
- Click Delete Selected.
