eTMF system documentation

[Sarah Wilmschen-Tober]

Dear all,
where would you file documentation regarding eTMF system management (e.g. eTMF system setup verification, eTMF change requests, eTMF user account requests and agreements)?
I would file it in 01.01.01 (and in 10.04.01 only system documentation from the eCRF). Do you agree?
Thank you in advance for your help!
Sarah

[Eldin Rammell]

Hi Sarah,

Remember that the TMF is a trial-specific repository. So whilst the records you mention need to be retained and could be reviewed in an inspection, they would not be expected in the TMF. Most companies have a separate system in which they maintain validation records and records of system management, such as user access requests, change requests etc.

Kind regards,
Eldin.

[Sarah Wilmschen-Tober]

Hi Eldin,
thank you for your response.
Maybe I was not clear. All the documents I refer to are trial-specific so we need to file these records in the TMF.
Thanks a lot in advance for your feedback!
Kind regards,
Sarah

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