title: Revising the ECRIN standard requirements for information technology and data management in clinical trials.
abstract: The pilot phase of the ECRIN (European Clinical Research Infrastructure Network) certification programme for European data centres, in late 2011, led to a substantial revision of the original ECRIN standards, completed by June 2012. The pilot phase, the conclusions drawn from it and the revised set of standards are described. Issues concerning the further development of standards and related material are discussed, as are the methods available to best support that development. A strategy is outlined based on short-lived specific task groups, established as necessary by a steering group drawn from ECRIN-ERIC. A final section discusses possible future developments.
authors.affiliation: Coordination Centre for Clinical Trials, Heinrich Heine University, Moorenstrasse 5, 40225, Düsseldorf, Germany. Christian.Ohmann@uni-duesseldorf.de
authors.forename: Christian
authors.initials: C
authors.lastname: Ohmann
authors.forename: Steve
authors.initials: S
authors.lastname: Canham
authors.forename: Catherine
authors.initials: C
authors.lastname: Cornu
authors.forename: Jochen
authors.initials: J
authors.lastname: Dreß
authors.forename: François
authors.initials: F
authors.lastname: Gueyffier
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Kuchinke
authors.forename: Enrico B
authors.initials: EB
authors.lastname: Nicolis
authors.forename: Michael
authors.initials: M
authors.lastname: Wittenberg
mesh_terms: D002568:Certification; D002986:Clinical Trials as Topic / Q000592:standards* / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D019983:Guideline Adherence; D017408:Guidelines as Topic; D063025:Health Information Management / Q000592:standards* / Q000706:statistics & numerical data; D006801:Humans; D016247:Information Storage and Retrieval / Q000592:standards* / Q000706:statistics & numerical data; D008490:Medical Informatics / Q000592:standards* / Q000706:statistics & numerical data; D016730:Program Development; D012107:Research Design / Q000592:standards* / Q000706:statistics & numerical data; D009626:Terminology as Topic; D018875:Vocabulary, Controlled
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