Bioequivalence and Bioavailability Forum • Participation databases

Participation databases [Design Issues]

posted by Helmut – Vienna, Austria, 2020-01-01 11:23 (2017 d 05:40 ago) – Posting: # 21046
Views: 11,894

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!

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

[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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

Admin contact
23,428 posts in 4,929 threads, 1,680 registered users;
53 visitors (0 registered, 53 guests [including 6 identified bots]).
Forum time: 18:03 CEST (Europe/Vienna)

To know that we know what we know,
and to know that we do not know what we do not know,
that is true knowledge. Nicolaus Copernicus

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz