Documenting Artifacts that are Not Applicable

[Nick Hryciw ('her issue')]

We are trying to determine the best way to document an artifact that is not applicable for a study. For example, if a study is open-label, we will never file documents related to blinding, etc. Our current eTMF file structure is configured to display all artifacts, regardless if the artifact is applicable. Should we document a Note to File to indicate if a document is not applicable, and therefore, the artifact will remain empty? What is the best way to handle this so an auditor does not think the document is missing?

[Eldin Rammell]

Hi Nick,

If you cannot adjust the index of your eTMF solution due to feature limitations then the most common approach is to capture this in the TMF Plan. This should be the authoritative description of your expected documents.

Regards,
Eldin.

[Nick Hryciw ('her issue')]

Thank you!

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