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RegisterMonitoring CROs [BE/BA News]
posted by Helmut 
– Vienna, Austria, 2014-12-07 15:08 (3808 d 20:12 ago) – Posting: # 13999
Views: 21,048
Hi ElMaestro,
Why not? The sponsor should be happy that I detected it and not an inspector years later. I had three cases in my career (stupid mistakes – not fraud). The studies were repeated. In two cases CROs repeated studies for free and in one the net costs where shared 50/50 (because the sponsor could have detected the mistake during his monitoring; I discovered a mistake in the randomization after the study was completed).
Why?
Why?
No way. But: I have heard about ECGs where in the PDFs the subject-ID was edited in Acrobat. Stupidly the edited ID was in Arial and everything else in Courier. I guess I would be able to see this.
I don’t – though I have some sympathies for idiot savants.
❝ As a private auditor you cannot write you have detected fraud.
Why not? The sponsor should be happy that I detected it and not an inspector years later. I had three cases in my career (stupid mistakes – not fraud). The studies were repeated. In two cases CROs repeated studies for free and in one the net costs where shared 50/50 (because the sponsor could have detected the mistake during his monitoring; I discovered a mistake in the randomization after the study was completed).
❝ You will end up with a bunch of lawyers fees to pay.
Why?
❝ 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.
Why?
❝ 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?
No way. But: I have heard about ECGs where in the PDFs the subject-ID was edited in Acrobat. Stupidly the edited ID was in Arial and everything else in Courier. I guess I would be able to see this.
❝ If you answer yes …
I don’t – though I have some sympathies for idiot savants.
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Helmut Schütz
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Complete thread:
- Bioequivalence in prime time TV news Dr_Dan 2014-12-05 08:42 [BE/BA News]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bioequivalence in prime time TV news nobody 2014-12-05 08:51
- Bioequivalence in prime time TV news Ohlbe 2014-12-05 14:10
- Bioequivalence in prime time TV news nobody 2014-12-05 16:56
- Bioequivalence in prime time TV news Helmut 2014-12-05 17:24
- Bioequivalence in prime time TV news nobody 2015-01-23 17:08
- Bioequivalence in prime time TV news nobody 2014-12-05 16:56
- Bioequivalence in prime time TV news Ohlbe 2014-12-05 14:10
- If you know German… Helmut 2014-12-05 13:27
- If you know German… nobody 2014-12-05 14:20
- Monitoring CROs Helmut 2014-12-05 17:49
- Monitoring CROs nobody 2014-12-05 18:02
- Monitoring CROs ElMaestro 2014-12-06 22:10
- Monitoring CROsHelmut 2014-12-07 14:08
- Monitoring CROs nobody 2014-12-12 10:51
- Inspectors ≠ teachers (rather = examiners) Helmut 2014-12-12 14:41
- Monitoring CROs nobody 2014-12-12 10:51
- Monitoring CROsHelmut 2014-12-07 14:08
- Monitoring CROs Helmut 2014-12-05 17:49
- If you know German… nobody 2014-12-05 14:20
- RCA ElMaestro 2014-12-07 01:06
- Speculations Helmut 2014-12-07 14:41
- Speculations nobody 2014-12-07 17:31
- Speculations ElMaestro 2014-12-07 20:20
- Speculations Helmut 2014-12-07 14:41
- Bioequivalence in prime time TV news nobody 2014-12-05 08:51
Ing. Helmut Schütz