Adverse Event and Unanticipated Problem Reporting Policy

NHLBI Policy	Related Documents: N/A	Approval Date: 2/2/2009
		Effective Date: 2/2/2009
Adverse Event and Unanticipated Problem Reporting Policy		Contact(s): Jewell Martin
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Policy

This 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.

Studies involving human subjects research must include procedures for identifying, monitoring, and reporting adverse events(AE) and unanticipated problems(UP). For clinical trials and studies with greater than minimal risk, these procedures should be described in the study's Institutional Review Board(IRB)-approved data and safety monitoring (DSM) plan which is sent to the NHLBI. (See NHLBI Data and Safety Monitoring Policy)
Expedited reporting to the NHLBI Program Official or Project Officer (PO) is required for unanticipated problems(UP) or unexpected serious adverse events (SAE) that may be related to the study protocol as follows:

Any event or problem that is

Unexpected;

AND

Possibly, probably, or definitely related to study participation;

AND one of the following:

Is fatal, life-threatening, or serious (SAE + UP)

Within 7 calendar days

Suggests greater risk of harm to study participant(s) than was previously known or recognized(UP)

Within 30 calendar days

Expedited SAE/UP reports to NHLBI should include the following elements:
- Study title, grant/contract number, PI name
- Description and date of the event or problem, including why it merits expedited reporting
- When available, date(s) when the event was reported to applicable governing bodies (e.g., IRB, Food and Drug Administration)
- Any corrective action planned or taken in response to the event or problem (e.g., study suspension, consent or protocol changes, additional training or security measures)

Investigators are responsible for reporting to and following the guidance of any other applicable oversight bodies, including (but not limits to) the following:
- Institutional Review Broad (IRB) or Ethics Board
- Office for Human Research Protections (OHRP)
- Food and Drug Administration (FDA)
- Monitoring entity ---- e.g., independent monitoring group, data and safety monitoring board (DSMB) or observational study monitoring board(OSMB)
- NIH Office of Biotechnology Activities (OBA)

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 Charts

Illustrated 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.