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Title: Open Label Pilot Study of Empanel for the Treatment of Alcohol Use Disorder NCT #: NCT04502589 Document date: August 10, 2021 (approval date) Document Type: Informed Consent Formic IRB PROTOCOL
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Define the study objectives and research questions.
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Select the study population and inclusion/exclusion criteria.
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Develop the study protocol, including study procedures and data collection methods.
04
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Who needs open label pilot study?

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Researchers conducting feasibility studies for larger clinical trials.
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Pharmaceutical companies testing the safety and efficacy of new drugs.
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Healthcare providers assessing the potential impact of a new treatment or intervention.
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Open label pilot study is a type of study in which both the researchers and participants know which treatment is being administered.
Researchers conducting a study that falls under the category of open label pilot study are required to file the necessary documentation.
To fill out an open label pilot study, researchers need to include all relevant information about the study design, participants, treatments, and outcomes.
The purpose of an open label pilot study is to assess the feasibility of a larger study and gather preliminary data on the effectiveness of a treatment.
Information such as study design, participant demographics, treatment details, and study outcomes must be reported on an open label pilot study.
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