IRB Adverse Event Forms

  • Adverse Event Reporting Form, revised 4/11/12 (DOC)
    • Use this form to report to the IRB unexpected adverse events in research participants enrolled under Children's IRB approval.
     
  • Adverse Event Reporting Guidelines, revised 6/26/09 (DOC)
    • Use this form to understand the reporting requirements for adverse events that occur in research participants enrolled under Children's IRB approval. These are the minimal reporting requirements. The form explains what events are to be reported and in what time frame. It also provides useful definitions used to describe the types of adverse events.