Auditor NDA/CDA [GxP / QC / QA]

posted by ElMaestro  – Denmark, 2021-03-12 08:32 (818 d 01:52 ago) – Posting: # 22262
Views: 1,532

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

Complete thread:

UA Flag
Activity
 Admin contact
22,620 posts in 4,741 threads, 1,612 registered users;
32 visitors (0 registered, 32 guests [including 10 identified bots]).
Forum time: 11:25 CEST (Europe/Vienna)

Outside his own ever-narrowing field of specialization,
a scientist is a layman.
What members of an academy of science have in common
is a certain form of semiparasitic living.    Erwin Chargaff

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5