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FULFILL Pharmaceuticals U.S.A., Inc. Protocol FAVICOVUS201Version 6.0 15July2020Open Label, Randomized, Controlled Phase 2 ProofofConcept Study of the Use of Favipiravir Compared to Standard of Care
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What is open label randomized controlled?
An open label randomized controlled trial (RCT) is a type of clinical trial where participants are randomly assigned to different treatments, but both the researchers and participants are aware of the treatment assignments.
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Researchers or organizations conducting clinical trials involving human participants are required to file open label randomized controlled trials for regulatory approval and compliance.
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To fill out an open label randomized controlled trial, researchers must provide detailed information about the study design, population, randomization process, treatment protocols, and outcome measures in the appropriate regulatory forms.
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The purpose of open label randomized controlled trials is to evaluate the effectiveness and safety of a treatment while allowing both participants and researchers to know the treatment being administered.
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Information that must be reported includes trial objectives, study design, participant eligibility criteria, randomization methods, treatment details, outcome measures, and statistical analysis plans.
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