title: Database of adverse events occurring in clinical studies--useful and necessary?
abstract: Due to an amendment of the German Drug Act ethic committees must be informed of all serious or unexpected adverse events occurring during a clinical study. This means that ethic committees may have to reevaluate their recommendations. A database is presented in order to help an ethic committee in decision making. Preliminary results indicate that this database may be helpful in future and-additionally-may be the beginning of pharmacovigilance.
authors.affiliation: Chamber of Physicians Nordrhein, Tersteegenstr. 31, 40474 Düsseldorf, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Hopf
authors.forename: M
authors.initials: M
authors.lastname: Wermuth