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Adverse Event and Unanticipated Problem Reporting PolicyPolicyThis policy describes the requirement for reporting adverse events (AE) and unanticipated problems (UP) for the clinical research studies funded in whole or in part by National Heart, Lung, and Blood Institution(NHLBI) extramural programs.
NOTE: Communications from the above oversight bodies regarding any applicable SAE/UP must be reported to NHLBI according to the ( see NHLBI Data and Safety Monitoring Policy) Diagrams and ChartsIllustrated below (per OHRP guidance), many adverse events are not unanticipated problems, and some adverse events are also unanticipated problems. For example, a serious adverse event that is unexpected and at least possibly related to study participation is also by definition an unanticipated problem. An unanticipated problem may not necessarily be an adverse event, which is the case when the problem does not cause actual harm to participant(s). For example, if a laptop computer with sensitive, identifiable study data is stolen, this theft places the participants at greater risk of psychological or social harm; this is an unanticipated problem that is not an adverse event. Another example of an unanticipated problem that is not an adverse event is if the FDA announces that one of your study drugs is tainted (e.g., with paint chips), yet no participant experiences any adverse effects.
References21 CFR 312.50, General Responsibilities of the Sponsor 21 CFR 312.32(a), IND Safety Reports ICH E6 5.0 Sponsor, Good Clinical Practices NHLBI Data and Safety Monitoring Policy, 10/31/2008 NIH Guidelines for Research Involving Recombinant DNA Molecules, April 2002 NIH Office of Biotechnology Activities (OBA) Revision Record
Last update: [ February 1, 2012 ]
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