Deviations from the Clinical Investigation Plan Sample Clauses

Deviations from the Clinical Investigation Plan. ‌ Except in an emergency, prior approval by the study Sponsor is required for changes in or deviations from the investigational plan. If the changes or deviations may affect the scientific soundness of the study or the rights, safety, or welfare of participants, FDA and IRB approval is required. Every effort should be made to comply with the requirements of the protocol. Deviations will be recorded with an explanation for the change. The study Sponsor is responsible for analyzing the deviations and assessing their significance. Corrective action will be implemented to avoid repeat deviations.
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