Serious Adverse Event
(SAE) Reporting

Investigator Requirements for Reporting Serious Adverse Events
to the Institutional Review Board (IRB)

Important:

• Reporting requirements for adverse events are only for SERIOUS adverse events. The event is SERIOUS and should be reported when the patient outcome is:  death, life-threatening, hospitalization (initial or prolonged), disability, congenital anomaly, and requires intervention to prevent permanent impairment or damage. 
• In addition to the forms required for FDA and/or the study sponsor for adverse events, you must complete and submit the Meharry Medical College Adverse Event Reporting forms.
• If the adverse event results in a revision of the informed consent statement, a study amendment form and two copies of the revised consent form must also be submitted. 
• For reasons of confidentiality, do NOT include patient names in you adverse event report. You may instead substitute a code.
• The reporting requirements of others (e.g. sponsors, FDA, hospital) are not satisfied or precluded by this report.
• Newly discovered information and unanticipated risks will require the IRB to review your protocol more than once a year.

Reporting Requirements:

• Any serious and unexpected adverse events that may or may not be associated with the study intervention that occur on-site (i.e. to a subject enrolled on an Meharry or Nashville General Hospital protocol) must be reported to the IRB Office within 48 hours of notification of the event.
• Any serious and unexpected adverse events that may or may not be associated with the study intervention that occur at an external site (i.e. regarding a non-Meharry or Nashville General Hospital subject) must be reported to the IRB Office within 5 working days after receipt from the sponsor.
• Any adverse events that do not meet the above reporting requirements may be reported at the time of continuing review or via independent Data and Safety Monitoring Board reports.

 Please contact the Human Protections Administrator in the IRB office if you have any further questions

The PI is expected to be fully familiar with the ICHE 6 reporting guidelines www.fda.gov/cder/guidance/959fnl.pdf for Serious Adverse Event Reporting