[Katie Kelly]

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

[Katie Kelly]

Thank you Todd, that approach makes sense for certifying copies. Are Adobe-signed documents do not contain any certificate unfortunately, would you recommend we wet-ink sign all documents?

[Author]

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