Each participating centre will need to obtain ethics approval from their local Ethics Committee prior to the start of the study and document this on the Centre Report. If a centre does not have a local Ethics Committee, then approval must be sought from some other source such as an Education Board, or a local health authority and this information must also be documented on the Centre Report.
Note: This manual has been updated as of 10 September 2015. If you visited or downloaded the manual before this date, please replace it with this latest version.
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