CTIS documents filing in the eTMF

[Sylwia Matuszewska]

Since the change in the EU submissions via CTIS system, I have a question how do you plan to file the Regulatory section in the eTMF? Do you plan to download the documents from the CTIS and file all in the REG section? We are currently discussing this subject in my company and I would like to hear how other companies plan this change into eTMF filing process. Thank you.

[Leon Kuik]

Hi Sylwia, this is an ongoing discussion in my organization, too.

Some tough nuts to crack – like the question if the redacted documents need to be in the TMF, or not.
But also questions if available non-eTMF solutions that can do a better job on submission dossier management should be considered as the repository for these documents (with a reference to that system in the eTMF).
Looking forward to hear thoughts and ideas from others.

[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, 5 months ago by Rebecca Siegl.

[Chelo Ramirez]

As per your experience, are Sponsors requesting to file redacted documents submitted to CTIS, also in the eTMF. If so, do you compile the complete and redacted versions in one file or do you file separetly?

Many thanks in advance,
KRs
Chelo

[Author]

Posts