ICH GCP type of the data [GxP / QC / QA]

posted by Beholder  – Russia, 2021-04-05 13:56 (1885 d 13:01 ago) – Posting: # 22301
Views: 5,063

Hi to all!
Does sb know what exactly type of data can be recorded directly on the CRFs and be considered to be source data as stated ICH GCP (see below)?
“6.4.9 The identification of any data to be recorded directly on the CRFs (i.e. no prior written or electronic record of data), and to be considered to be source data.”
Thx in advance.
—
Best regards
Beholder

Complete thread:

UA Flag
Activity
 Admin contact
23,653 posts in 4,991 threads, 1,571 registered users;
498 visitors (0 registered, 498 guests [including 47 identified bots]).
Forum time: 02:57 CEST (Europe/Vienna)

I’m all in favor of the democratic principle
that one idiot is as good as one genius, but I draw the line
when someone takes the next step and concludes
that two idiots are better than one genius.    Leo Szilard

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