Questions about data manipulation [GxP / QC / QA]

posted by Helmut Homepage – Vienna, Austria, 2024-04-30 13:46 (49 d 03:53 ago) – Posting: # 23968
Views: 3,309

Hi QA,

❝ Is it advisable that CRO use this software (after implementing the SOP within the system) …

Yes, but…

❝ … and prove that no such manipulation was done during BE study.

Unfortunately you cannot prove that in the statistical sense (null hypothesis = no manipulation, alternative hypothesis = manipulation). The assessment contains still a subjective element. Sorry.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
23,057 posts in 4,840 threads, 1,641 registered users;
37 visitors (0 registered, 37 guests [including 7 identified bots]).
Forum time: 17:40 CEST (Europe/Vienna)

You should treat as many patients as possible with the new drugs
while they still have the power to heal.    Armand Trousseau

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5