What are adverse events and when do I have to report them?
The Principal Investigator must submit a written report to the IRB in writing (or to IRB office in Amarillo) of all unanticipated adverse events or problems (both serious and non-serious) involving risks to subjects that occur at TTUHSC or an affiliated entity that are known to be related or may possibly be related to the research activities within two (2) business days after becoming aware of the event. The Principal Investigator is responsible for the accurate documentation, investigation and follow up of all possible study related adverse events and unanticipated problems involving risks to subjects. Reports of all adverse events or unanticipated problems must be retained in the Principal Investigator files. The IRB may conduct an expedited review of the event if there is no change in the risk/benefit ratio, the research proposal, or the consent form; otherwise, full Board review is required. The Chair or designee, at the time of expedited review, may refer any adverse event to the
