DATABASE OF ADVERSE EVENTS OCCURRING IN CLINICAL-STUDIES - USEFUL ANDNECESSARY

Authors
HOPF G WERMUTH M
Citation
G. Hopf et M. Wermuth, DATABASE OF ADVERSE EVENTS OCCURRING IN CLINICAL-STUDIES - USEFUL ANDNECESSARY, Pharmacoepidemiology and drug safety, 7, 1998, pp. 70-75
Citations number
NO
Categorie Soggetti
Pharmacology & Pharmacy
Journal title
Pharmacoepidemiology and drug safety → ACNP
ISSN journal
10538569
Volume
7
Year of publication
1998
Supplement
1
Pages
70 - 75
Database
ISI
SICI code
1053-8569(1998)7:<70:DOAEOI>2.0.ZU;2-V
Abstract
Due to an amendment of the German Drug Act ethic committees must be in formed of all serious or unexpected adverse events occurring during a clinical study. This means that ethic committees may have to reevaluat e their recommendations. A database is presented in order to help an e thic committee in decision making. Preliminary results indicate that t his database may be helpful in future and - additionally - may be the beginning of pharmacovigilance. (C) 1998 John Wiley & Sons, Ltd.