Monitoring CROs [BE/BA News]

posted by ElMaestro  – Denmark, 2014-12-06 23:10 (3868 d 23:14 ago) – Posting: # 13997
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Hi Hötzi,

❝ Who do you mean by “they”? IMHO sponsors should monitor CROs. If they didn’t find the falsi­fied ECGs (unlike the French inspector) that would be a sign of incompetence.


Thanks for sharing your endless wisdom.:-)
I think there are nuances here. As a private auditor you cannot write you have detected fraud. You will end up with a bunch of lawyers fees to pay. Writing that you see conduct which may not be fully compatible with the principles of GCP blah blah is what most have to resort to. Second, actually realising fraud is present is not always completely easy. Let me show you, say, 10 ECGs of which 3 come from the same person sampled 2 minutes apart. Do you think you would see it? If you answer yes then your popularity might be sharply increasing over the next year or so.:-D Check out Robert Evans for comparison.
—
Pass or fail!
ElMaestro

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