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New HHS Guidelines Clarify Adverse Event Reporting

Law360 (February 23, 2007, 12:00 AM EST) -- On January 15, 2007, the Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) released new clinical trial guidelines on reviewing and reporting unanticipated problems and adverse events that occur in clinical trials conducted or supported by federal departments or agencies. See http://www.hhs.gov/ohrp/policy/AdvEvntGuid.htm.

The guidance comes in response to longstanding calls by Institutional Review Boards (IRBs) and the research community for harmonized federal guidelines on the reporting of clinical trial adverse events. OHRP, Request for Public Comment on OHRP's Draft Guidance on...
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