What adverse events need to be reported to the IRB?
A revised Adverse Events Policy was released on April 13, 2004. Currently, “internal” (occurring to subjects in a study conducted by Columbia faculty or NYPH staff) serious and unanticipated adverse events must be reported within 48 hours to the IRB. External serious and unanticipated adverse events which are possibly related to a study intervention need to be reported to the IRB within 5 business days.All serious and/or unexpected adverse events that do not meet the new reporting policy and are reported to be reported to the IRB in summary form at the time of continuing review in summary of all adverse events.
A revised Adverse Events Policy was released on April 13, 2004. Currently, “internal” (occurring to subjects in a study conducted by Columbia faculty or NYPH staff) serious and unanticipated adverse events must be reported within 48 hours to the IRB. External serious and unanticipated adverse events which are possibly related to a study intervention need to be reported to the IRB within 5 business days. All serious and/or unexpected adverse events that do not meet the new reporting policy and are reported to be reported to the IRB in summary form at the time of continuing review in summary of all adverse events.
