open-label BE trials maintain blindness [Study Per­for­mance]

posted by ElMaestro  – Denmark, 2023-10-14 19:39 (57 d 16:46 ago) – Posting: # 23755
Views: 1,056

Hi kimhaung,

❝ How do open-label BE trials maintain blindness until the database is locked?

I had a small coughing fit reading this line :-)

Can I ask:
  1. Who do you want to keep blind and why? Monitor, PI, bioanalytical staff, QA, sponsor, PK staff, statistics staff, pharmacy staff, clinical staff etc?
  2. Are the people who create the rand. code also the people who do NCA? is it the same people who do stats?
  3. Who has access to the rand. code? I do not mean who should have access.
  4. Do some of the staff with access to the rand. code also undertake other functions by any chance?

Pass or fail!

Complete thread:

UA Flag
 Admin contact
22,823 posts in 4,786 threads, 1,633 registered users;
29 visitors (0 registered, 29 guests [including 5 identified bots]).
Forum time: 11:26 CET (Europe/Vienna)

In these matters the only certainty is
that nothing is certain.    Pliny the Elder

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz