[ECRIN standard requirements for good clinical practices-compliant data management in multinational clinical trials].

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

https://www.ncbi.nlm.nih.gov/pubmed/27839710

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;: