2005N-0038 - Adverse Event Reporting to Investigational Review Boards Public Hearing
FDA Comment Number : EC2
Submitter : Mr. Norman Goldfarb Date & Time: 02/14/2005 10:02:34
Organization : First Clinical Research
Drug Industry
Category :
Issue Areas/Comments
I recommend that clinical research investigators code adverse events and serious adverse events so they can be easily classified and trends identified. None of the public coding systems (e.g., SNOMED and MedDRA) is entirely suitable, but making one suitable is certainly practical. A directory of possible adverse events would educational for investigators. Sponsors could provide investigators with an abbreviated list of possible adverse events. Anything not on that list would be an unexpected adverse event.

I also recommend a standard form for investigators to use when reporting events. Ideally, it would be on a website that would notify the sponsor and IRB immediately when events are posted. The same recommendations apply to IND Safety Reports going to sites and IRBs. In addition, IND Safety Reports shoudl include some statistical trend analysis so sites and IRBs can see the big picture. The websites would not be much more complicated than this docket.