Participation databases [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2020-01-01 10:23 (656 d 12:05 ago) – Posting: # 21046
Views: 5,129

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
21,737 posts in 4,546 threads, 1,543 registered users;
online 5 (0 registered, 5 guests [including 3 identified bots]).
Forum time: Monday 23:29 CEST (Europe/Vienna)

Law is mind without reason.    Aristotle

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