Participation databases [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2020-01-01 11:23 (1628 d 17:08 ago) – Posting: # 21046
Views: 7,422

Hi ElMaestro,

❝ ❝ Where should such a system be located? At the EMA?


❝ This would be an interesting discussion. A legal discussion, probably?


Given the European GDPR of 2016 for sure.

❝ ❝ BTW, I like ANVISA’s system. The database is run by the agency and volunteers are blocked from participation in another study for six months.


❝ This is much like Ovis and its siblings.


THX for your summary. I was much too naïve. What a nightmare for inspectors!

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;
135 visitors (0 registered, 135 guests [including 90 identified bots]).
Forum time: 05:31 CEST (Europe/Vienna)

If you tell the truth you don’t have to remember anything.    Mark Twain

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