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What will FDA lift a clinical hold that was imposed to protect subjects from investigator misconduct?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

FDA will lift a clinical hold imposed to protect subjects from investigator misconduct when the grounds for the hold no longer apply. The sponsor of the affected study may, while the clinical hold is in place, present evidence to FDA to show that it has taken steps to protect study subjects, e.g., by replacing the investigator who is charged with the misconduct or, for example, in the case of a sponsor-investigator, by submitting a monitoring plan. If FDA concludes, based on this evidence, that the study subjects are no longer exposed to an unreasonable and significant risk of illness or injury, the hold will be lifted. In all instances, if a sponsor of a study that has been placed on clinical hold requests in writing that the clinical hold be removed and responds to the issues identified in the clinical hold order, FDA will respond in writing to the sponsor within 30 calendar days of receipt of the request and response. FDA will either remove or maintain the clinical hold and will state the reasons for its decision.

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