The eTMF allows a study owner to make a document that was once activated with incorrect metadata/content or that is no longer needed obsolete. There are two actions available for making a document obsolete:
- “Make Obsolete and Retire” marks the current version as Obsolete.
- “Make Obsolete and Revise” marks the current version as Obsolete and sends the document back for Rework.
Make Obsolete and Retire
To make a document obsolete and retired (e.g., if it has reached its expiration date), navigate to a Final document, open its associated Actions menu and select “Make Obsolete and Retire.”
On the Make Obsolete and Retire window, select a Reason for the action, enter any additional Comments if necessary, and then click Make Obsolete and Retire. The document status will no longer appear as Final and will instead appear as Obsolete. An obsolete document is shown in the image below.
Make Obsolete and Revise
To make a document obsolete and and revise it (e.g., the content or metadata needs correction), navigate to the Final document, open its associated Actions menu, and select “Make Obsolete and Revise.”
On the Make Obsolete and Revise window, select a Recipient for the rework task, select a Reason, enter any additional Comments that may be helpful for the selected recipient, and click Make Obsolete and Revise. The document status will now appear as Obsolete AND In QC, and a task will be assigned to the selected recipient.
