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What is cytel issues?
Cytel issues refer to critical to quality elements in a clinical trial.
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CROs or biostatisticians involved in the clinical trial are required to file cytel issues.
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Cytel issues are typically filled out using statistical software and following specific guidelines.
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The purpose of cytel issues is to ensure the quality and integrity of the clinical trial data.
What information must be reported on cytel issues?
Cytel issues must include details on statistical methodologies, data analysis, and any deviations from the original plan.
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