The Mark Item Fulfilled function allows a Study Owner to record that a study item will not be fulfilled by a document in the eTMF. Marking a study item as fulfilled will allow the item to be tracked in the metrics as a fulfilled study item as opposed to having the item show as missing.

Examples of reasons why an item will not be fulfilled by a document and should be marked as fulfilled:

• Termination of a site or vendor
• Natural disaster that results in the loss of documents
• Document maintained in another system
• Subject no longer part of study

To mark study item as fulfilled, choose an unfulfilled study item, open its associated Actions menu and select “Mark as Fulfilled.”.

This will open the Mark as Fulfilled component window.

Choose a reason from the Reason drop-down, enter additional Comments if necessary, and enter the URL to the document (if available). If a URL has been entered, you can click the Test URL button to verify that the URL is correct and works as expected. The Test URL button will open a separate browser tab, or window, depending on your browser settings. To finish, click Mark Fulfilled.

The Study Item’s icon will now indicate to show that the item is Fulfilled without Content. The Study Item record will include a hyperlink to the document (if specified), and the change to the Study Item will be recorded in the Audit Trail.