Trial monitoring
An independently chaired Trial Steering Committee (TSC)
will be responsible for overall supervision of the trial including
ratification of the protocol prior to the commencement of thetrial. The TSC will meet at least six monthly to monitor
recruitment, study progress and any serious adverse events. In
addition to the authors, the TSC will be made up of a subcommittee
consisting of the independent members including;
a patient representative (the parent of an eligible young person),
an independent expert in music therapy, an independent
biostatistician and an independent expert on clinical trials. A
representative from the Northern Ireland Music Therapy
Trust and the trial statistician are also members of the TSC.
The independent members of the sub-committee will also
convene separately, and report any recommendations to the
full TSC, which will be implemented by the trial team as
necessary and appropriate.