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Clinical Trial RegulationsVersion 3.0 March 2021 ___Dr. Mariam Adobe Alabama Chief Executive Officer National Health Regulatory Authority 1ContentsPreamble: ...........................................................................................................................................................................................................

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A Phase 12 study typically refers to a specific phase in clinical trials or regulatory submissions, often focusing on the final stages of testing new drugs or interventions.

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Filling out a Phase 12 study involves compiling data from clinical trials, adhering to regulatory guidelines, and submitting detailed reports on methodology, results, and safety assessments.

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The purpose of a Phase 12 study is to evaluate the efficacy and safety of a new intervention before it can be approved for general use, providing critical data to regulatory bodies.

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Key information to be reported in a Phase 12 study includes study design, patient demographics, results of the trial, adverse effects, and statistical analysis.

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