Can of worms [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2020-01-30 15:12 (305 d 18:19 ago) – Posting: # 21105
Views: 2,546

Hi jag,

I agree with Helmut.
My top three for scientific advice is Sweden, Sweden, and Sweden.
You will of course not fall for the temptation to take sc. advice in the countries which are the most attractive business-wise.

It will likely be a 10(3). This is Europe, so if the study is conducted here you will be facing an IEC, not IRB, technically. And note that the IEC may be a bottle-neck. They can say no, even if the authority will say yes.

Try and discuss the case with different CROs, I think you find that several of them (in EU their numbers are limited) have been in situation before and have been discussing the matter with other sponsors + authorities as well as with IECs.
What are you actually going to measure? :-)

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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