[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.

• This reply was modified 1 year ago by Rebecca Siegl.

[Rebecca Siegl]

Hello,
I would also classify it under Zone 06 and then under Non-IP Documentation. A Non-IP is per definition ‘a medicinal product which is not classed as an IMP in a trial, but may be taken by subjects during the trial.’ So in my opinion this section is the closest we can get to a suitable place for AxMP in the TMF.

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