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Adverse Event Report Form

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Adverse Event Report Form

When to Use this Form: The Responsible Project Investigator (RPI) should complete and sign this form and submit it with related attachments for any event that falls into either Category A or Category B, below:

Category A - Any serious adverse event that occurs within 48 Hours of participation in the research:
Serious adverse events are those resulting in death, a life-threatening experience, hospitalization or prolongation of existing hospitalization, a persistent or significant disability or capacity, or a congenital anomaly or birth defect. Every serious adverse event must be reported on this form, even if the event does not appear to be associated with the research protocol. If applicable, also file an FDA Adverse Event Report (at http://www.fda.gov/cder/aers/). In addition, the IRB Office 217.333.2670; irb@illinois.edu) should be notified within 24 hours of discovery of any serious adverse event.

Category B - Any event for which all three of the following are true:

(1) Subject or Risks to Subject or Others Adversely Affected:  An event or outcome has occurred that has resulted in harm to the subject, has affected the subject detrimentally, has worsened as a result of their participation, or that has resulted in increased risk to the subject or to others, whether or not the risk has actually resulted in harm (for example, misplacing a subject's research records would constitute an increased risk event that should be reported).

(2) Unexpected Event:  The event or outcome was not described as a risk of participation in the research, or, though described as a risk, the event or outcome has occurred with unexpected severity or frequency.

(3) Possibly, Probably, or Definitely Related Event: The event or outcome was definitely related to participation in the research or it's reasonable to conclude that the event or outcome was related to participation, or it's possible the event or outcome was related but not enough information is available at this time to assess the likelihood of this possibility.