[ECRIN standard requirements for good clinical practices-compliant data management in multinational clinical trials].
Référentiel ECRIN pour la conformité aux bonnes pratiques de gestion des données des essais cliniques multinationaux.
Academic studies
Data management
Gestion de données
Information technology
Quality reference
Référentiel qualité
Systèmes d’information
Études cliniques institutionnelles
Journal
Therapie
ISSN: 1958-5578
Titre abrégé: Therapie
Pays: France
ID NLM: 0420544
Informations de publication
Date de publication:
Historique:
received:
09
03
2015
accepted:
28
05
2015
medline:
15
11
2016
pubmed:
15
11
2016
entrez:
15
11
2016
Statut:
ppublish
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. A group of experts produced the standards, by consensus. The first version was revised after two pilot audits for data centre certification were performed. The revised version includes 21 lists of five to ten standards, in three groups: information technologies, data management (DM) and "general". These standards offer a clear description of DM and IT requirements for clinical studies. Initially created for ECRIN certification purposes, they offer a very useful reference for academic DM structures.
Identifiants
pubmed: 27839710
pii: S0040-5957(16)31137-4
doi: 10.2515/therapie/2015042
pii:
doi:
Types de publication
English Abstract
Journal Article
Langues
fre
Sous-ensembles de citation
IM
Pagination
S11-S18Informations de copyright
Copyright © 2016. Published by Elsevier Masson SAS.