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

posted by Beholder  – Russia, 2021-04-05 11:56 (453 d 04:05 ago) – Posting: # 22301
Views: 1,050

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
22,181 posts in 4,647 threads, 1,572 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Saturday 16:01 CEST (Europe/Vienna)

Reach for the stars,
even if you have to stand on a cactus.    Susan Longacre

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