[ECRIN standard requirements for good clinical practices-compliant data management in multinational clinical trials].
Fiche publication
Date publication
octobre 2016
Journal
Therapie
Auteurs
Membres identifiés du Cancéropôle Est :
Pr BINQUET Christine
Tous les auteurs :
Cornu C, Donche A, Coffre C, Le Gouge A, Rym B, Vaugier I, Barbot F, Leizorovicz A, Juge N, Giraud C, Gueyffier F, Félin A, Mura T, Chevassus H, Binquet C,
Lien Pubmed
Résumé
Clinical studies involve an increasing amount of data collection and management. However, there is no specific quality standard sufficiently practical, in free access, and open for data management and the underlying IT-infrastructure in academic units. European Clinical Research Infrastructures Network (ECRIN) published standard requirements for certified data management units. We present a French version of these standards.
Référence
Therapie. 2016 Oct;: