EDT Requirement Status

The main purpose of EDT is to manage and report on the EDT Requirements status. When a document is added to one of the corresponding libraries on the clinical trial workspace, it has a Lifecycle Status of “Draft”. As the document progresses through its lifecycle, the system searches EDT to determine if there is a matching requirement. If it finds a matching requirement, the system will update the status to agree with the corresponding document’s status. When the document is approved, The EDT requirement will be set to “Final” and the document icon will be replaced with an icon indicating that the corresponding document is now declared a record.

Tip: The status column in EDT refelects the Lifecycle Status only. If the user initiates an optional eTMF Review workflow, the status in EDT will only reflect this in the Workflow Status and not in the Lifecycle Status since the document’s Lifecycle Status remains “Draft”.