Participation databases [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2020-01-01 10:23 2a02:8388:6bc2:ce80:ecf1:7da1:2052:4299 – Posting: # 21046
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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!

Cheers,
Helmut Schütz
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