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Occupational TherapyTraining ManualThis manual is intended to be used toguide occupational therapists while implementing the Johns Hopkins University School of Nursing CAPABLE? ProgramThis is written
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A capable trial, or randomized controlled trial (RCT), is a study design that randomly assigns participants into an experimental group or a control group to evaluate the effectiveness of an intervention.
Researchers or sponsors who conduct clinical trials are typically required to file a randomized controlled trial, particularly when seeking approval from regulatory agencies.
To fill out a randomized trial filing, researchers must follow specific guidelines set by regulatory bodies, providing details about study design, methodology, participant eligibility, and outcome measures.
The purpose of a randomized trial is to determine the efficacy and safety of an intervention or treatment by minimizing bias through random assignment.
Key information that must be reported includes study objectives, methodology, participant demographics, randomization process, interventions used, and statistical analysis plans.
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