Certificates of translations

[Sarah Wilmschen]

After translation of study documents, where do you file respective Certificates of Translations?

[Jennifer Huddleston]

Hi all,

I filed these documents as a ‘package PDF’ like:
Russian ICF v 2.0 20200311
Russian ICF v 2.0 20200311 – RUS-ENG translation 20200314
Russian ICF v 2.0 20200311 – ENG-RUS backtranslation 20200314
Russian ICF v 2.0 20200311 – Translation Certificate 20200314
Russian ICF v 2.0 20200311 – QA or Cert of Translation 20200314

For some trials, I put a coloured piece of paper between each of the documents to make it easier to navigate.

[Todd Tullis]

In the TMF Reference Model, translation documentation is a kind of “progeny record” (this is the term used on the Instructions and Glossary tab). The TMF RM states that progeny records belong filed with their related artifact (as described by Jennifer above).

eTMF systems have various ways of dealing with progeny records, but as long as the translation documentation can be seen as related & is accessible from the primary record that was translated, you should be good.

[Sarah Wilmschen]

Thank you very much for your helpful comments!

[Author]

Posts