Bioequivalence and Bioavailability Forum • Participation databases

Participation databases [Design Issues]

posted by Helmut – Vienna, Austria, 2019-12-31 19:01 (1571 d 06:43 ago) – Posting: # 21044
Views: 7,507

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.

—
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Helmut Schütz

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        National databases‽ Ohlbe 2020-01-02 16:36