Bioequivalence and Bioavailability Forum • Monitoring CROs

Monitoring CROs [BE/BA News]

posted by ElMaestro – Denmark, 2014-12-06 23:10 (3809 d 13:34 ago) – Posting: # 13997
Views: 20,978

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

Complete thread:

Bioequivalence in prime time TV news Dr_Dan 2014-12-05 08:42 [BE/BA News]
- 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
- 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
        
        Ethics? Helmut 2014-12-05 22:54
        
        Ethics? nobody 2014-12-06 14:23
      - Monitoring CROsElMaestro 2014-12-06 22:10
        
        Monitoring CROs Helmut 2014-12-07 14:08
        
        Monitoring CROs nobody 2014-12-12 10:51
        
        Inspectors ≠ teachers (rather = examiners) Helmut 2014-12-12 14:41
- 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