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RegisterParticipation databases [Design Issues]
posted by Helmut 
– Vienna, Austria, 2020-01-01 10:23 – Posting: # 21046
Views: 2,714
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!
» » 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 🖖
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Dif-tor heh smusma 🖖
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
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![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 ElMaestro 2020-01-02 18:19
- Great discussion Helmut 2020-01-02 17:14
- Great discussion Ohlbe 2020-01-02 16:57
- National databases‽ Ohlbe 2020-01-02 16:36
- Great discussion ElMaestro 2020-01-02 16:31
- National databases‽ Helmut 2020-01-02 13:06
- Participation databases ElMaestro 2020-01-01 12:23
- Participation databasesHelmut 2020-01-01 10:23
- Participation databases ElMaestro 2019-12-31 20:21
- Hb level ElMaestro 2019-12-31 17:21
- Hb level nobody 2019-12-31 15:46
Ing. Helmut Schütz