2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
FDA Comment Number : EC11
Submitter : Ms. Linda Levoy Date & Time: 03/25/2005 05:03:53
Organization : Overlake Hospital
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL

Investigators:

Investigators are required to report unanticipated adverse effects to sponsors and IRBs ?promptly?, and in no event later that 10 days, but there is no enforcement or penalty for being late. Therefore it does not happen very frequently.

Sponsors:

The same problem with delays holds true for sponsors reporting to IRBs and investigators. Sponsors are required to report the unanticipated adverse effects to IRBs and investigators within 10 working days after the sponsor receives notice, but there is no enforcement or penalty for being late. There is also vast over-reporting by investigators to the IRB. The protocols written by the sponsors are often not specific enough about what constitutes a reportable event. The event is supposed to be study related, serious, and unexpected, but many events that are reported do not meet these three criteria, thus overburdening the IRB. With the mountain of paperwork the IRB receives on SAEs, it becomes difficult to weed out the reports that do merit attention.

FDA:

Rather than numerous DMCs across the country getting paid by sponsors to do analysis of SAEs, the FDA should have an online format for the reporting of Serious Adverse Events by the investigators. The reports should be filed under the name of the drug / biologic / device, rather than the study title. IRBs should have direct access to the web site so that this information is readily obtainable. The FDA should do periodic, frequent analysis and summary of the reports and include this information on the site. This would allow IRBs to see the big picture, how the study drug / biologic / device is affecting patients across the country so that an informed decision can be made that both promotes research and protects patients.