Filenote and Correspondence

[Sarah Wilmschen]

Dear all, I have the following question: I learned that Correspondence does not need to be filed in the artifact ‘Relevant communications’ but may also be filed in the artifact of the corresponding document.
What about Filenotes? Could one also file them in the artifact where the corresponding document belongs or is it rather recommended to file them all in the artifact ‘Filenote’ of the respective zone?
Thank you for your help!

[Allison Grosik]

Hi Sarah,

From my experience, I have seen both scenarios for filenotes. More commonly I see the NTFs processed to the artifact of the corresponding document. This helps ensure the document is not lost in the ‘catch all’ Filenote artifact.
Be sure to capture the company’s decision on the study TMF index.

Best regards,
Allison Grosik
LMK Clinical Research Consulting

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