Nieuwe richtlijn toetsing multicentrisch onderzoek: procedure verbeterd, uitvoering wisselend

Nicolien J. Schepers, Marc G. Besselink

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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
Original languageDutch
Pages (from-to)A7328
JournalNederlands Tijdschrift voor Geneeskunde
Volume158
Publication statusPublished - 2014

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