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  • in reply to: PK Plan where do I file? #5047
    Maria Joshi
    Participant

    I have always used Zone 8. It order to really know what artifact to use, look at the info within the plan and match the content description to the reference model. Plans that i have looked at in the past describe methods, validation, etc. which is more in line with section 8.

    in reply to: Is eTMF access control necessary for multiple CROs? #5046
    Maria Joshi
    Participant

    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.

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