I work for a sponsor company and we contract CRO's to run our clinical studies and Trial Master Files.
We run a shadow TMF for each study, which so far has been handled well.
We are starting more and more studies and I feel the way we run the shadow TMF's is no longer efficient. I am working with our CTA to streamline the process, however as there are no published requirements for a shadow TMF, we are all struggling to agree on what documents need to be filed.
We currently save all documents and correspondence electronically and print everything to file in our archive. We feel this is too much; just electronic files could suffice as the CRO runs the main TMF for us.
Does anyone have any experience of running a shadow TMF and what do you keep in it?
What do you feel are key documents that need to be printed for inclusion in a paper shadow TMF?

Thank you