Catherine Cornu1, Anne Donche2, Carine Coffre3, Amélie Le Gouge3, Boulkedid Rym4, Isabelle Vaugier5, Frédéric Barbot5, Alain Leizorovicz6, Nadine Juge7, Céline Giraud8, François Gueyffier6, Alexandra Félin9, Thibault Mura10, Hugues Chevassus10, Christine Binquet9. 1. 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. 2. Service de pharmacologie clinique et essais thérapeutiques, CHU de Lyon, 69500 Bron, France. 3. Inserm, CIC 1415, CHRU de Tours, 37044 Tours, France. 4. Unité d'épidémiologie clinique, hôpital Robert-Debré, AP-HP, 75019 Paris, France; Inserm, U 1123 et CIC 1426, hôpital Robert-Debré, 75019 Paris, France. 5. Inserm CIC 1429, hôpital Raymond-Poincaré, AP-HP, 92380 Garches, France. 6. Service de pharmacologie clinique et essais thérapeutiques, CHU de Lyon, 69500 Bron, France; UMR 5558, université de Lyon, 69000 Lyon, France. 7. Inserm, CIC 1433, CIC-EC, 54000 Nancy, France; Pôle S2R, épidémiologie et évaluation cliniques, CHU de Nancy, 54000 Nancy, France. 8. Inserm, CIC1407, hôpital Louis-Pradel, CHU de Lyon, 28, avenue du Doyen-Lépine, 69500 Bron, France. 9. Inserm, CIC 1432, module épidémiologie clinique, 21079 Dijon, France; Centre d'investigation clinique, module épidémiologie clinique/essais cliniques, CHU de Dijon, 21079 Dijon, France. 10. Centre d'investigation clinique, CHU de Montpellier, 34295 Montpellier cedex 5, France; Inserm, CIC 1411, 34295 Montpellier cedex 5, 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.
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.
Keywords:
Academic studies; Data management; Gestion de données; Information technology; Quality reference; Référentiel qualité; Systèmes d’information; Études cliniques institutionnelles
Authors: Caleb J Ruth; Samantha Lee Huey; Jesse T Krisher; Amy Fothergill; Bryan M Gannon; Camille Elyse Jones; Elizabeth Centeno-Tablante; Laura S Hackl; Susannah Colt; Julia Leigh Finkelstein; Saurabh Mehta Journal: J Med Internet Res Date: 2020-08-13 Impact factor: 5.428