Bioequivalence and Bioavailability Forum • Participation databases

Participation databases [Design Issues]

posted by Helmut – Vienna, Austria, 2019-12-31 19:01 (1743 d 11:57 ago) – Posting: # 21044
Views: 8,588

Hi ElMaestro,

❝ Unfortunately money and ethics do not mix well. I think money is winning.....

Not only that. The volunteer-database of my CRO was linked (56k modem!) to “Cross-check” at the University Freiburg. Data shared: surname, given name, date & place of birth, nationality (ISO 3166-1 alpha-2), sex, and date of last participation. Most German CROs used this database (we were the only one in Austria).
Was shut down in August 1997 since not compliant with the German data protection law… Yep, personal data, unencrypted transfer. Great.
Nowadays I would concatenate the information into one field (likely the initials instead of the full name are sufficient) and transfer only a SHA-3. Everyone should be happy. Question: Where should such a system be located? At the EMA?

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. No fret, no pain.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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 databasesHelmut 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