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A Randomized Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients: The TOP-UP TrialImplementation Manual Intended Audience: Research Coordinators & Site InvestigatorsThis
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Determine the research question or hypothesis that will be tested in the trial.
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Define the study population and inclusion/exclusion criteria.
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Randomly assign participants to treatment groups.
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A randomized trial is a study in which participants are randomly assigned to receive either the treatment being tested or a control group, allowing for the evaluation of the treatment's effectiveness.
Researchers or organizations conducting randomized trials to assess the efficacy of a treatment or intervention are typically required to file the trial.
To fill out a randomized trial, researchers must provide detailed information including study design, participant eligibility, intervention details, and statistical analysis plans.
The purpose of a randomized trial is to minimize bias and establish a cause-and-effect relationship between an intervention and an outcome.
Key information reported includes study objectives, methodology, participant demographics, treatment details, outcomes measured, and statistical analyses.
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