ElMaestro
★★★

Denmark,
2021-03-09 18:22
(42 d 02:45 ago)

Posting: # 22254
Views: 557
 

 Auditor NDA/CDA [GxP / QC / QA]

Hi all,

Here's a problem that is gettíng bigger and bigger: I believe CROs, especially the very large ones, are increasingly asking auditors to sign CDAs/NDAs, which open up for lawsuits against the auditor.

When faced with it, I am flat out refusing it, noting that:
  1. I do not feel I am entirely independently if I need to handle the Sponsor's GCP-interest while at the same time have to worry about a lawsuit against me (and no, sponsors do not generally offer legal protection if this should happen).
  2. I am always working under a CDA with the sponsor anyway, and this is in part to protect the auditee.
  3. Precedent, especially with FDA inspectors, seems to suggest that regulators do not acknowledge auditor independence if there is an existing written agreement of any type between auditor and CRO (but granted, it isn't a matter they often look too rigorously into).

Some CROs have denied me access due to absence of a CDA.
This is becoming an increasingly big issue these years. I feel I can do absolutely nothing. With this post I wish to create awareness, and I'd be happy to hear other people's experience and/or opinions pro and con.

In three cases the NDA/CDA a CRO asked me to sign was so strict that my legal advisor told me I would technically be in breach of the confidentiality if I shared my audit report with the sponsor.:lookaround: We need to get rid of all this rubbish. CRO's please stop asking auditors to sign CDAs. Now.

Pass or fail!
ElMaestro
jag009
★★★

NJ,
2021-03-12 06:52
(39 d 14:15 ago)

@ ElMaestro
Posting: # 22261
Views: 401
 

 Auditor NDA/CDA

HI Maestro
»
» Here's a problem that is gettíng bigger and bigger: I believe CROs, especially the very large ones, are increasingly asking auditors to sign CDAs/NDAs, which open up for lawsuits against the auditor.

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

J
ElMaestro
★★★

Denmark,
2021-03-12 07:32
(39 d 13:35 ago)

@ jag009
Posting: # 22262
Views: 397
 

 Auditor NDA/CDA

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
Helmut
★★★
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Homepage
Vienna, Austria,
2021-03-12 10:48
(39 d 10:19 ago)

@ ElMaestro
Posting: # 22263
Views: 382
 

 Auditor NDA/CDA

Hi ElMaestro,

» It is in our SOPs …

… is the stupidest of all possible answers.

Dif-tor heh smusma 🖖
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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dshah
★    

India,
2021-03-16 06:29
(35 d 14:38 ago)

@ ElMaestro
Posting: # 22268
Views: 332
 

 Auditor NDA/CDA

Hi ElMaestro!
So if we have a CDA with Sponsor and CRO, weather can we consider as independent auditor?
And then what is the purpose of monitoring if we can't share observation with even sponsor?
Why Sponsor wants to go ahead with such CRO only?
Can we raise a concern with Regulatory body about demand of CRO and its implications?
The CDA demand by CRO is totally unacceptable.
Regards,
Dshah
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