“Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events”

Date: January 15, 2007

“Scope: This document applies to non-exempt human subjects research conducted or supported by HHS. It provides guidance on HHS regulations for the protection of human research subjects at 45 CFR part 46 related to the review and reporting of (a) unanticipated problems involving risks to subjects or others (hereinafter referred to as unanticipated problems); and (b) adverse events.”

http://www.hhs.gov/ohrp/policy/advevntguid.html

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