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Changes to the investigational plan or manufacturing process must be submitted to the FDA for approval if they significantly affect the validity of study data, risk-benefit ratio, scientific soundness of the study, or the rights, safety, or welfare of subjects. These changes should be submitted to the FDA as a supplement to the IDE protocol and must be approved by the FDA before being implemented.
Changes that do not meet the above criteria (e.g., adding follow-up visits, changing secondary endpoints, etc.) should be submitted to the FDA within 5 working days of implementation of the change. Minor changes to the purpose of the study, risk analysis, monitoring procedures, labeling, informed consent materials, and IRB information that do not affect the validity of study data, risk-benefit ratio, scientific soundness of the study, or the rights, safety, or welfare of subjects can be submitted with the annual report.
An investigator shall notify the sponsor and the reviewing IRB (21 CFR 56.108(a) (3) and (4) of any deviation from the investigational plan to protect the life or physical well-being of a participant in an emergency. Such notice shall be given as soon as possible, but in no event later than 5 working days after the emergency occurred. Except in such an emergency, prior approval by the sponsor is required for changes in or deviations from a plan, and if these changes or deviations may affect the scientific soundness of the plan or the rights, safety, or welfare of human participants, FDA and IRB in accordance with (21 CFR 812.35(a)). For more information, see Changes or Modifications during the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff.