Bioequivalence and Bioavailability Forum • National databases‽

National databases‽ [Design Issues]

posted by Helmut – Vienna, Austria, 2020-01-02 13:06 (998 d 11:19 ago) – Posting: # 21050
Views: 6,175

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.

—
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Helmut Schütz

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Complete thread:

Normal Reference Range Vs Pre-defined site normal values cakhatri 2019-12-17 11:35 [Design Issues]
- Normal Reference Range Vs Pre-defined site normal values ElMaestro 2019-12-17 23:21
- Hb level Ohlbe 2019-12-29 17:04
  - OT Helmut 2019-12-29 18:49
  - Hb level nobody 2019-12-31 10:47
  - Hb level ElMaestro 2019-12-31 15:19
    - Hb level nobody 2019-12-31 15:46
      - Hb level ElMaestro 2019-12-31 17:21
        
        Hb level nobody 2019-12-31 17:26
        Participation databases Helmut 2019-12-31 18:01
        
        Participation databases ElMaestro 2019-12-31 20:21
        
        Participation databases Helmut 2020-01-01 10:23
        
        Participation databases ElMaestro 2020-01-01 12:23
        
        Participation databases nobody 2020-01-02 10:35
        Participation databases Ohlbe 2020-01-02 12:18
        
        National databases‽Helmut 2020-01-02 13:06
        
        Great discussion ElMaestro 2020-01-02 16:31
        
        Great discussion Ohlbe 2020-01-02 16:57
        
        Great discussion ElMaestro 2020-01-02 18:19
        
        WTF 😡 Helmut 2020-01-02 18:42
        
        Great discussion Helmut 2020-01-02 17:14
        
        National databases‽ Ohlbe 2020-01-02 16:36