Submit 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.