Reply To: Working with a CRO who won’t file ‘outside’ documents

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#3989
Katie Kelly
Participant

Hi all,
Thanks for your input and suggestions. I thought you’d be interested in an update – this CRO agreed to file our ‘outside’ documents as long as we dictate at the beginning of the study which TMF Ref Model sections (note: NOT specific documents) we expect will contain ‘outside’ documents and we have written agreement that the CRO isn’t responsible for review and QC of these documents.

I hope this helps others!

Katie