Is eTMF access control necessary for multiple CROs?

[Mai Nishihara]

Hi all,
Have you experienced managing eTMF where multiple CROs upload documents and be able to view them?
One study will involve two CROs as document uploaders, one for monitoring, and the other for DM.
In general, should sponsors control each CRO’s access to documents which might include other CROs’ information, such as CRA’s email address, and work procedures?
Perhaps clarifying in a contract between a sponsor and multiple CROs not to reveal confidential information from documents on eTMF could be ideal.
If you share your thoughts, it would be a great help.

[Maria Joshi]

If a sponsor owns the TMF then it is appropriate that they also manage all the access. It should not matter if vendors and CROs file into the TMF as the expectation for filing is that it is related to the study and tells the story. I don’t quite follow the concern for CRA’s email as confidential information as this info is already part of a study contact list which is a core document in the TMF irrespective of who is uploading or access. If you can elaborate more on the concerns maybe others can chime in as well.

[Mai Nishihara]

Hi Maria, thank you for your comment on my question. You have given me a clear picture of TMF telling the study story and documents can be filed by CROs under the sponsor’s appropriate access management.
Thank you for your valuable time.

[Author]

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