[Yasmina Bourima]

It depends on the document. For instance, the documents (ICFs, CTP, IB, etc.) that are submitted to Authorities/IEC-IRB should always be found in the TMF because the track change version is also submitted, at least this is the case in Germany.

KR
Yasmina

[Yasmina Bourima]

The master version would also be the main document if several countries are involved, which one would file under Study Level. The country-specific translated ones under Country Level and the site-specific changes ones under Site Level. For me, a template is a version that still needs to be edited. Without specific content and only a given structure.

[Yasmina Bourima]

Templates should not be filed in the TMF only Master Versions.

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