Bioequivalence and Bioavailability Forum • Participation databases

Participation databases [Design Issues]

posted by Helmut – Vienna, Austria, 2020-01-01 11:23 (1716 d 19:45 ago) – Posting: # 21046
Views: 8,024

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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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 databasesHelmut 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

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