OHRP still grappling with how to report AEs to IRBs, despite guidance.(Adverse event reporting)(Office for Human Research Protections)(Report)

Adverse Event Reporting News | December 17, 2007| | Copyright

BOSTON -- The reporting of adverse events and unanticipated problems varies from FDA to OHRP despite efforts at harmonization, and while there is some effort to get as much consistency as possible into the reporting process--notably a federal-wide electronic portal for adverse events reporting that will be available in the near future and will streamline submissions--it still remains problematic.

That was the message of a panel speaking at the annual HRPP conference in Boston here. Panelists were Sara Goldkind, M.D., senior bioethicist at FDA; Michael Carome, M.D., ...

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