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Managing protocol deviations in clinical trials is crucial to ensure the integrity of the study results and patient safety. Classifying protocol deviations into categories helps in assessing their severity and determining the appropriate course of action. By classifying protocol deviations into these categories and providing examples, study teams can better understand the nature and impact of deviations, prioritize corrective actions, and ensure compliance with regulatory requirements and protocol standards throughout the clinical trial. By following this roadmap, clinical trial teams can effectively manage protocol deviations, ensure compliance with regulatory requirements, and safeguard the integrity of study data and participant safety throughout the trial.
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