EMA: Guideline on computerised systems and electronic data in clinical trials [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2021-06-30 10:41 (362 d 18:02 ago) – Posting: # 22442
Views: 957

Dear all,

the EMA’s Good Clinical Practice Inspectors Working Group published a draft guideline (end of consultation 17 December 2021), which will replace the ‘Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials’ of 2010.

Dif-tor heh smusma 🖖 [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
22,178 posts in 4,646 threads, 1,571 registered users;
online 3 (0 registered, 3 guests [including 1 identified bots]).
Forum time: Tuesday 04:43 CEST (Europe/Vienna)

It is futile to do with more things
that which can be done with fewer.    William of Ockham

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