title: [New procedure for review of multicentre studies: procedure improved, implementation variable].
abstract: In 2012 the Dutch Central Committee on Research Involving Human Subjects (CCMO) introduced a new procedure to obtain medical ethics committee approval for multicentre studies in the Netherlands. A recent cohort study demonstrated that the 2012 procedure is a more efficient one. Our additional prospective evaluation of two multicentre trials confirmed this finding; the implementation of the 2012 procedure in 16 participating centres shortened the local review procedure by a median of 20 days (from 45 to 25 days). However, 6 of the 16 centres (38%) apparently did not follow the new procedure. Strict procedural adherence has the potential to further streamline the process for obtaining ethical approval for multicentre trials in the Netherlands.
authors.affiliation: *De deelnemers aan de werkgroep zijn te vinden op www.pancreatitis.nl.
authors.forename: Nicolien J
authors.initials: NJ
authors.lastname: Schepers
authors.forename: Marc G
authors.initials: MG
authors.lastname: Besselink
mesh_terms: D026724:Ethical Review; D004992:Ethics, Medical; D032984:Ethics, Research; D006801:Humans; D015337:Multicenter Studies as Topic; D009426:Netherlands; D011446:Prospective Studies