IRB Adverse Event Forms

Adverse Event Reporting Form (DOC 51KB)

Use this form to report to the IRB unexpected adverse events in research participants enrolled under Children's IRB approval.

Adverse Event Reporting Guidelines (DOC 42KB)

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.