Adverse Events
Unanticipated Problem/Adverse Event Reporting Guidelines (Local and Non-Local) 
 
Local Unanticipated Events 
 
Investigators must promptly report to the IRB–Spokane any unanticipated problems or unanticipated adverse events within 5 business days of the event or upon gaining knowledge of the event via Click.  Reports are submitted using the "Reportable New Information" (RNI) workspace. 

      Non-Local Unanticipated Events  
       
      Non-local Unanticipated Problems/Adverse Event Reports (Sponsor generated IND Safety Reports) will be accepted only if it is unanticipated, serious and possibly, probably or definitely related to the study within 5 business days of receipt by the principal investigator with a cover letter that contains ALL of the following information: Reports are submitted using the "Reportable New Information" (RNI) workspace. 
       
      1. Description of event;
      2. Identifies all previous safety reports concerning similar adverse experiences;
      3. Analyzes the significance of the current adverse experience in light of the previous reports;
      4. Outlines a corrective action plan (such as a consent form change or protocol change); and,
      5. If no revision to the protocol or informed consent, justification of reason
        Do not submit reports that do not contain all of the above information.  They will be returned as incomplete.