4.3 Main features of RCTs

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When developing an RCT you must create a detailed and comprehensive protocol which is approved by an appropriate ethics board or committee. This protocol should include the following information:
The rationale for the RCT included a detailed literature review
Definition of the hypothesis (research question)
Proposed methods to be used: the study objectives, sample size calculations, defined reference population, the intervention and control treatments, intervention and control group selection.
Procedures to obtain informed consent from participants
Quality assurance and safety considerations
Minimum criteria and collection of baseline variable data
Procedure for the random allocation of study participants (randomisation)
How follow-up and monitoring compliance will be achieved within all groups