Interim versions in eTMF: to keep or delete

[Evgenia Delyagina]

Dear group,
I have a question regarding handling of interim versions of documents in eTMF. By “interim” I mean those which are produced between 1.0 and 2.0 (1.1, 1.2, 1.3 etc) when the system is used to author documents.
While only final (and superseded) versions will be seen to normal users, e.g. 1.0 and 2.0, will the interim versions still reside with IT or will they be deleted? Will the interim versions be archived together with the whole eTMF at the end of the study or will you consider deleting them?
And last but not least, would you consider migrating interim versions to a new system if the study is chosen to be migrated or would you only migrate final and superseded versions (i.e. 1.0, 2.0 etc.)?

[Ilse Snieders]

Interesting question, I would like to hear from someone about this with experience with eTMFs.

At our hospital, we only file final / superseded versions and clean up before final long term archiving (i.e. check on work/interim versions in between which can be deleted).

Regards, Ilse

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