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OHRP still grappling with how to report AEs to IRBs, despite guidance.(Adverse event reporting)(Office for Human Research Protections)(institutional review board)(United States. Food and Drug Administration)
- Article from:
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BioResearch Compliance Report
- Article date:
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December 1, 2007
- Author:
- Cezanne, Jeannette
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Copyright informationCOPYRIGHT 2007 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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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 federalwide 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., associate director of regulatory affairs at OHRP; and Amy Patterson, M.D., director of the Office of ...