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Rebecca Siegl

Hi Sylwia and Leon,

in my company we are filing screenshots of the system Part I (as download of dossier, etc. most of the time not possible) and the cover letter under country-level (for global studies) Regulatory in the eTMF. The uploaded documents themselves (Protocol, IB, etc.) will be filed in their corresponding zones according to the RM V3.

For Part II system screenshots will be filed unter country-level IRB/IEC. Documents themselves will again be filed in their corresponding zones.

If more than one MSC is involved we tag all the involved countries in the Metadata of the document in the eTMF.

For redacted documents we always ask our Sponsor whether they would like them filed in the eTMF or not.

I am curious to see if there are many other approaches.