Safety Reports & Unanticipated Adverse Device Effects
All Unanticipated Adverse Device Effects (UADEs) must be submitted to Schulman within ten (10) business days of the investigator’s knowledge of the event using the 
Safety Report/UADE Submission Form.
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 and Safety Reports will be provided to the submitting party by e-mail.
Upon receipt and review of a UADE or Safety Report, the Board may request additional information from the sponsor or investigator. If the Board determines, after review of a UADE or Safety Report, that additional information should be provided to subjects, the Board will recommend an addendum and/or revision to the Schulman approved Informed Consent Document (ICD) and will notify the sponsor and/or the investigator of the revisions. The sponsor or investigator may also request that new safety information be provided to study subjects; however, the sponsor's/investigator's request will be subject to Board approval.