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Open accessProtocolHolly Man sell, 1 Nicola Rosalie,2 Patricia WestThielke,3 Jenny Richard,4 Christopher Daley,5 Rahul Main,6 Ahmed Shower,6 Auxin Liu,7 David Blackburn1To cite: Mandell, Roseann,
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Identify the research question or hypothesis that you want to investigate through the randomised controlled trial.
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A randomised controlled trial (RCT) is an experimental study design that randomly assigns participants to different groups to test the effects of a specific intervention or treatment.
Researchers and organizations conducting clinical trials involving human subjects are typically required to file a randomised controlled trial.
To fill out a randomised controlled trial, one must provide details about the study design, objectives, participant eligibility criteria, randomization method, intervention details, and data analysis plan.
The purpose of a randomised controlled trial is to determine the efficacy and safety of new treatments or interventions while minimizing bias by randomly assigning participants.
Information that must be reported includes the trial registration number, study design, participant demographics, intervention details, outcomes measured, and statistical methods.
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