Bioequivalence and Bioavailability Forum

Gimme some data! [Study As­sess­ment]

posted by jag009  – NJ, 2013-08-20 21:54 (4695 d 03:35 ago) – Posting: # 11330
Views: 8,664

Hi Helmut,

❝ Likely nothing. If you audit the site now, which answer do you expect? Even if they come up with something (relying on their memory “Oops, I remember it was just five minutes late, not 35. Sorry!”) – will it be more credible than was written (GCP…) in the CRF? Fishy.

❝ Whenever possible monitor at least the first period of all studies.

The joke of the day... My monitor was there but left after 3 hours because she was satisfied with the performance observed during her stay (-1 day upto 3 hour post-dose draw).

Complete thread:

• I thought I have seen everything jag009 2013-08-19 20:40 
  • I thought I have seen everything Helmut 2013-08-20 15:43
    • I thought I have seen everything jag009 2013-08-20 18:09
      • Gimme some data! Helmut 2013-08-20 18:16
        • Gimme some data! jag009 2013-08-20 18:19
          • Gimme some data! Helmut 2013-08-20 18:34
            • Gimme some data!jag009 2013-08-20 19:54