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Unanticipated Adverse Device Effects

SponsorsSubmit Unanticipated Adverse Device Effects (UADEs) to Schulman within 10 business days of the investigator’s knowledge of the event using the UADE Submission Form. However, if the UADE involves a death it must be reported within 24 hours of discovery.

If you have questions regarding whether or not an event is considered a UADE, refer to the protocol description of a UADE, consult with the sponsor or refer to FDA Guidance on UADEs.

Acknowledgement of receipt for UADEs will be provided to the submitting party by e-mail.

Upon receipt and review of a UADE, the Board may request additional information from the sponsor or investigator. If the Board determines that additional information should be provided to subjects, the Board will recommend an addendum and/or revision to the informed consent and will notify the sponsor and/or the investigator of the revisions. The sponsor or investigator may also request the Board approve new safety information be provided to study subjects.