CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy (Siège social : 29 avenue du Maréchal de Lattre de Tassigny, CO 60034, 54035 NANCY CEDEX
Hôpital Central : 29 Avenue du Maréchal de Lattre de Tassigny, 54035 Nancy
Hôpitaux de Brabois / Enfants : Rue du Morvan, 54500 Vandœuvre-lès-Nancy
Maternité régionale :10 Avenue Dr Heydenreich, 54000 Nancy - France)
CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy (Siège social : 29 avenue du Maréchal de Lattre de Tassigny, CO 60034, 54035 NANCY CEDEX
Hôpital Central : 29 Avenue du Maréchal de Lattre de Tassigny, 54035 Nancy
Hôpitaux de Brabois / Enfants : Rue du Morvan, 54500 Vandœuvre-lès-Nancy
Maternité régionale :10 Avenue Dr Heydenreich, 54000 Nancy - France)
Abstract : CONTEXT: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.METHODS:A group of experts produced the standards, by consensus. The first version was revised after two pilot audits for data centre certification were performed.RESULTS:The revised version includes 21 lists of five to ten standards, in three groups: information technologies, data management (DM) and "general".CONCLUSIONS: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.
Catherine Cornu, Anne Donche, Carine Coffre, Amélie Le Gouge, Boulkedid Rym, et al.. Référentiel ECRIN pour la conformité aux bonnes pratiques de gestion des données des essais cliniques multinationaux. Thérapie, EDP Sciences, 2016, ⟨10.2515/therapie/2015042⟩. ⟨hal-01815100⟩