National databases‽ [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2020-01-02 12:06 2a02:8388:6bc2:ce80:ecf1:7da1:2052:4299 – Posting: # 21050
Views: 1,145

Hi Ohlbe,

» It looks like I've opened a can-o'worm discussion here...

Those are the best ones!

» » 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.
»
» They're not the only country with a national system. That's also the case in […] France.
» Our database is managed by the Ministry of Health. It includes […] amount of money paid to the subject (there is a maximum of 4500 € per 12-month period, which has not been modified since 2006 !).

Adjusting for the annual inflation rates in France it should be ~5,355 €, right?

» » Question: Where should such a system be located? At the EMA?
»
» Or at the Commission ? Ideally the EU would have a single database, in order to prevent cross-participation in various countries.

What else? That’s why Europol runs one database which is accessible by all member states.

» But it would be more likely to be considered a matter of national competence, with national databases.

Freedom of travel is one of the basic principles in the EU. In order to prevent “volunteer-tourism” national databases would have to synchronize their data pools – probably on a daily basis. With – soon – 27 members states + Norway, Iceland, Liechtenstein we end up with \(\frac{n!}{(27+3-2)!2!}=435\) 1:1 connections.
If we consider only the EU, still 351. Not joking.

I’m pretty sure that at least one of Murphy’s laws will hit. IMHO, national databases wouldn’t make any sense.

Cheers,
Helmut Schütz
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