Continuing Review

Federal requirements state that all research must be reviewed at no less than annual intervals.

The purpose of continuing review is to review an entire study and determine that the anticipated risks and benefits are reflected in the actual experience of subjects and that the safeguards in place at the time of original approval are, in fact, adequate to ensure the safety of subjects.

It is the Principal Investigator's responsibility to respond to the continuing review requirements as state in the initial approval.

Protocols involving high risk may require more frequent review. The IRB may require frequent review or reports after a specific number of subjects are enrolled or have completed the study. The terms of the review and the written documentation required for that special review are determined at the time the original approval is granted.

Continuing Review Report Form

Continuing Review Report Form Instructions

Adverse Event Addendum for Continuing Review

Study Changes/ Modifications Table

Continuing Review Packet Checklist

General Information

Packet Preparation Instructions