2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
FDA Comment Number : EC17
Submitter : Ms. Mary Ann Heddon Date & Time: 04/13/2005 06:04:45
Organization : South Georgia Medical Center
Category : Health Professional
Issue Areas/Comments
This is an additional comment our IRB wanted to submit for consideration. They would like to see greater analysis and discussion with each SAE to assist them in putting the event into perspective. Even assigning a level of urgency or severity to the event would help them give the report an appropriate response; they're not talking about grading an individual event, but giving them an indication of how concerned they should be about the information.

(NOTE: This comment was sent by e-mail prior to locating this comment form)