Participation databases [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2020-01-01 11:23 (1126 d 19:07 ago) – 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!

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