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FDA's guidance addresses adverse reporting of items
Here's FDA advice in nutshell
In April, 2007, the Food and Drug Administration (FDA) issued its draft "Guidance for Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting — Improving Human Subject Protection."
The guidance addresses IRB concerns about how investigators and sponsors interpret regulatory requirements about reporting unanticipated problems.
"IRBs note that they receive increasingly large volumes of individual adverse event reports — often lacking in context and detail — that are inhibiting their ability to assure the protection of human subjects," the draft guidance states.
"IRBs reported difficulties in reviewing and interpreting the significance of information when large volumes of individual adverse event reports are received in isolation (neither aggregated nor analyzed) at sporadic intervals during the course of a study," the guidance says.
The FDA recommendations in the draft guidance are as follows:
The FDA draft guidance offers these examples of when adverse experiences should be reported to the IRB as unanticipated problems: