Adverse Event Reporting Policy Change

IRB-01 has updated the policy for the reporting of local and non-local deaths.

• Previous policy: All local deaths and non-local deaths (study related or not) are considered Serious AND Unexpected and should be reported within five working days of discovery using the Serious and Unexpected AE Reporting Form.
• New policy: IRB-01 considers all local deaths and non-local deaths (considered by the local PI or project Study Chair to be related or possibly related to study participation) to be Serious AND Unexpected, even if it is a possible outcome of disease progression. All local deaths and non-local deaths (considered related or possibly related to study participation) must be reported within five working days of discovery, even if the PI considers the local death to be unrelated to the study. A non-local death considered to be unrelated can be reported at the time of continuing review on the Cumulative Adverse Event Tracking Log.

The IRB-01 Policy & Procedures Manual, the Definitions for Adverse Event (AE) Reporting, the Adverse Event Evaluation & Reporting Guide, and the Serious and Unexpected AE Reporting Form have all been updated to accurately reflect these changes.