Participation databases [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2020-01-01 10:23  – Posting: # 21046
Views: 2,714

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 🖖
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
20,795 posts in 4,354 threads, 1,446 registered users;
online 26 (4 registered, 22 guests [including 9 identified bots]).
Forum time: 10:02 CEST (Europe/Vienna)

I’m not a pessimist,
I’m just a well informed optimist.    José Saramago

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