Paperless files

[pburns]

Does the sponsor have to keep paper copies of all documents, or can they keep electronic versions alone?

Specifically: Protocols, ICF, PIS etc.

Can sponsor oversight be paperless?

Thank you

[Vyara Stefanova]

Hi,
it is actually absolutely acceptable to have many documents in the TMF only as electronic records. The trend in the TMF is actually to go to electronic TMFs and the rule is that if the document is created and signed/approved (when appropriate) electronicaly it could be available only as electronic file. If otherwise you have documents signed on paper (not with electronic signature) or stapted you need to scan them (with some appropriate resolution) and archive them as scaned copies (if required by the sponsor) and in their original format - as a paper.
There is a paper of EMA on this topic as well - here is the link: http://www.ema.europa.eu/docs/en_GB/...C500138893.pdf
Hope this helps,
Vyara

[a123456]

There is also a very useful position paper by the MHRA on this very forum. In the section on electronic processes etc. It says what the MHRA expects for scanning of records for electronic storage.