Auditor NDA/CDA [GxP / QC / QA]

posted by ElMaestro  – Denmark, 2021-03-12 07:32 (35 d 23:04 ago) – Posting: # 22262
Views: 381

Hi jag009,

» ??? Why would an auditor needs to sign a CDA with the CRO that he's visiting on behalf of the sponsor???

Yes why, especially when a CDA is already existing between Sponsor and CRO which should covers those things?
But try and make your case towards a project manager who needs to revert to their legal department. "It is in our SOPs that you need to sign" if often the rhetorical answer I get, and that is not an invitation for dialogue.

This is real life and it is getting common.

Pass or fail!
ElMaestro

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