Bioequivalence and Bioavailability Forum

Gimme some data! [Study Assessment]

posted by Helmut – Vienna, Austria, 2013-08-20 20:34 (4282 d 14:32 ago) – Posting: # 11327
Views: 7,005

Hi John,

❝ ❝ ❝ Reason for deviation? Couldn't get blood from sites of puncture! 35mins!???? how many time did they poke on the subjects arm(s)!!!!!

❝ ❝ Do you believe in this “reason”?

❝

❝ What can I do?

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.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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

Gimme some data! [Study As­sess­ment]

Complete thread:

Gimme some data! [Study Assessment]