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Human Subjects Division (HSD)

Announcements

Instruction changes to the Status Report Form

Apr 24, 2009 at 1:04pm

 

1. A change in the definition of a Serious Adverse Event has been made to the Status Report Form (doc. # J-324).  The definition has been expanded to provide accurate information about current reporting requirements, and to be consistent with the current reporting instructions on the Adverse Event Report Form (doc. # U-755).

 

Please see the new, and the old definitions below, as excerpted from the Status Report Form:

 

NEW DEFINITION:

A serious adverse event (SAE) is when the subject outcome is death, hospitalization, life-threatening, disability and/or incapacity, congenital anomaly, pregnancy involving significant risk to the fetus, or the event requires intervention to prevent the outcomes listed above. The SAE should be reported immediately IF there is a reasonable possibility* the event is attributable to the study. 

·          *The UW defines ‘reasonable possibility’ as “more likely than not,” that is, there is a >50% likelihood of the event having been caused by or partially caused by the research or arising from the circumstances of the research.  Problems are considered unrelated to research participation if they are caused solely by:  A subject’s underlying disease, disorder or condition or other circumstances unrelated to the research activities.

 

OLD DEFINITION:

A serious adverse event (SAE) is when the subject outcome is death, hospitalization, life-threatening, disability and/or incapacity, congenital anomaly, pregnancy involving significant risk to the fetus, or the event requires intervention to prevent the outcomes listed above. The SAE should be reported immediately.

 

2. An instuction was added to the Consent Materials section of the Status Report Form (doc. # J-324) instructions.  The new instructions were added to aid in clarification of what consent materials need to be sent in with the Status Report Form.  Please see the new instruction below:

 

–   Do not submit copies of consent forms signed by individual subjects but rather a copy of the consent form(s)/materials you use to consent prospective subjects.