View operation history of expired file
An expired file in eTMF refers to a clinical trial document—study protocol, informed consent form, case report form, or else—that has reached its expiration period determined by regulatory requirements or internal procedures.
Proper management of expired files is crucial to ensure regulatory compliance and facilitate efficient record-keeping. In eTMF, you can dismiss an expired file and, if needed, revoke it back. The complete history of such actions with expired files you can review with the Operation History feature.
-
In the eTMF application header, select the TMF.
-
In the Study List table that appears, select the study for which you need to view an expired file operation history.
Figure 1. Selecting study
-
On the page that opens, in the left pane, select Study Details > Expired Files.
Figure 2. Expired files page
-
On the Expired Files page that opens, optionally you can sort the report data by study-, country-, and site-level files.
Figure 3. Sorting expired files by level
-
In the Expired Files table, go to the file of your interest and in the Actions column next to it, select Operation History
.
Figure 4. Accessing operation history
-
In the Operation History dialog that opens, view the history of actions with the file, who performed them, and when.
Figure 5. Viewing expired file operation history
-
Select
to close the dialog.
You have viewed the complete history of actions with the expired file.