2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
FDA Comment Number : EC9
Submitter : Mrs. Mary Ann Heddon Date & Time: 03/25/2005 05:03:04
Organization : South Georgia Medical Center
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I'm a research nurse who prepares submissions to our IRB, including review of adverse events. SAEs are filed under the IND of the studies they occur on. Following the narrative, a statement is usually given to help put the event into perspective that reports how many of this type event have occured under this IND. It would be much more helpful to report how often an event has occured under any IND. A searchable database that lists every type of event that has occured with any study drug would be extraordinarily helpful in putting any single event into perspective. Frequently an event is judged to be not related to a study drug, and yet the statement is made that over 100 cases of this "unrelated" SAE have been reported. It's probably time to consider that maybe the event IS related to the study drug if it's been reported that many times. Our IRB meets today at noon. I'll be soliciting additional comments from them to submit to you. Thank you for your efforts to improve adverse event reporting and the role it plays in the protection of our research participants.