This policy pertains to external problems (adverse events) or other materials emerging from sites other than the University of Miami or affiliated institutions within multicenter studies in which UM is engaged.
A general principle is that investigators at all participating institutions within multicenter studies should learn of external problems (adverse events) that require prompt reporting via reports that are distributed by the sponsor, coordinating center or data safety monitoring committee. Summary reports generated by the sponsor and/or data monitoring committee (when applicable) should be submitted for review at the time of study continuation.
External events that do not meet the criteria of unanticipated problems and have no effect on the risks to subjects participating at UM do not require reporting to the UM IRB. External problems that are unanticipated and increase risk to subjects who are participating locally (i.e. they require a change in the protocol or consent documents) or that occur in studies in which UM is the prime awardee or coordinating center in a multicenter study should be reported to the UM IRB within 10 calendar days of their becoming known. Changes in the protocol or consent forms that occur in response to external problems should be submitted to the UM IRB as amendments
External unanticipated problems that occur in clinical trials sponsored by cooperative groups (RTOG, COG etc) do not require reporting to the UM IRB.
A. Safety Notices, Informational Items and Reports:
Federal regulations do not require that safety notices or other informational items or reports from sponsors or a non-UM coordinating center in a multi-site study be submitted to the IRB.
UM principal investigators should maintain copies of external unanticipated problem reports, safety notices and related materials which shall be made available to the IRB upon request.