title: [ECRIN standard requirements for good clinical practices-compliant data management in multinational clinical trials].
abstract: BACKGROUND
  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.
authors.affiliation: Inserm, CIC1407, hôpital Louis-Pradel, CHU de Lyon, 28, avenue du Doyen-Lépine, 69500 Bron, France; Service de pharmacologie clinique et essais thérapeutiques, CHU de Lyon, 69500 Bron, France; UMR 5558, université de Lyon, 69000 Lyon, France. Electronic address: catherine.cornu@chu-lyon.fr.
authors.forename: Catherine
authors.initials: C
authors.lastname: Cornu
authors.affiliation: Service de pharmacologie clinique et essais thérapeutiques, CHU de Lyon, 69500 Bron, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Donche
authors.affiliation: Inserm, CIC 1415, CHRU de Tours, 37044 Tours, France.
authors.forename: Carine
authors.initials: C
authors.lastname: Coffre
authors.affiliation: Inserm, CIC 1415, CHRU de Tours, 37044 Tours, France.
authors.forename: Amélie
authors.initials: A
authors.lastname: Le Gouge
authors.affiliation: Unité d'épidémiologie clinique, hôpital Robert-Debré, AP-HP, 75019 Paris, France; Inserm, U 1123 et CIC 1426, hôpital Robert-Debré, 75019 Paris, France.
authors.forename: Boulkedid
authors.initials: B
authors.lastname: Rym
authors.affiliation: Inserm CIC 1429, hôpital Raymond-Poincaré, AP-HP, 92380 Garches, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Vaugier
authors.affiliation: Inserm CIC 1429, hôpital Raymond-Poincaré, AP-HP, 92380 Garches, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Barbot
authors.affiliation: Service de pharmacologie clinique et essais thérapeutiques, CHU de Lyon, 69500 Bron, France; UMR 5558, université de Lyon, 69000 Lyon, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Leizorovicz
authors.affiliation: Inserm, CIC 1433, CIC-EC, 54000 Nancy, France; Pôle S2R, épidémiologie et évaluation cliniques, CHU de Nancy, 54000 Nancy, France.
authors.forename: Nadine
authors.initials: N
authors.lastname: Juge
authors.affiliation: Inserm, CIC1407, hôpital Louis-Pradel, CHU de Lyon, 28, avenue du Doyen-Lépine, 69500 Bron, France.
authors.forename: Céline
authors.initials: C
authors.lastname: Giraud
authors.affiliation: Service de pharmacologie clinique et essais thérapeutiques, CHU de Lyon, 69500 Bron, France; UMR 5558, université de Lyon, 69000 Lyon, France.
authors.forename: François
authors.initials: F
authors.lastname: Gueyffier
authors.affiliation: Inserm, CIC 1432, module épidémiologie clinique, 21079 Dijon, France; Centre d'investigation clinique, module épidémiologie clinique/essais cliniques, CHU de Dijon, 21079 Dijon, France.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Félin
authors.affiliation: Centre d'investigation clinique, CHU de Montpellier, 34295 Montpellier cedex 5, France; Inserm, CIC 1411, 34295 Montpellier cedex 5, France.
authors.forename: Thibault
authors.initials: T
authors.lastname: Mura
authors.affiliation: Centre d'investigation clinique, CHU de Montpellier, 34295 Montpellier cedex 5, France; Inserm, CIC 1411, 34295 Montpellier cedex 5, France.
authors.forename: Hugues
authors.initials: H
authors.lastname: Chevassus
authors.affiliation: Inserm, CIC 1432, module épidémiologie clinique, 21079 Dijon, France; Centre d'investigation clinique, module épidémiologie clinique/essais cliniques, CHU de Dijon, 21079 Dijon, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Binquet
keywords: Academic studies; Data management; Gestion de données; Information technology; Quality reference; Référentiel qualité; Systèmes d’information; Études cliniques institutionnelles