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.
 
The PI is responsible to review the information provided, assign causility, sign and date all Unanticipated Problem/Adverse Event Reports.  If all pertinent information is not available or the PI is not available within the 5 day reporting window, the following steps must be taken:
 
  1. Report the initial/known details of the unanticipated problem/adverse event to the IRB via e-mail, phone or fax - always include the IRB number, name of PI, subject ID, date of event and brief explanation of the unanticipated problem/adverse event (this must be done within the 5 day reporting window). 
  2. Fax or e-mail the completed unanticipated problem/adverse event report form (must include PI signature) within 10 days of your initial report described in #1 above.  If there are extenuating circumstances that will cause the completed report to be longer than 10 days, it is your responsibility to communicate this information to the IRB.
 
The IRB will stamp your unanticipate problem/adverse event report with a "received" date and return to you via fax/e-mail as acknowledgment of receipt.   If you do not receive this acknowledgment within 5 days of submission, please contact the IRB.
 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.  The report must be submitted to the IRB within 10 days of receipt by the principal investigator with a cover letter that contains ALL of the following information: 
 
  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
    1. Policy:   See Policy and Procedures
    2. Algorithm: see above link    
  Do not submit reports that do not contain all of the above information.  They will be returned as incomplete.