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Continuing Review Tools

Events and Deviations Tables

The Events and Deviations Tables are tracking tools researcher teams can use throughout the year to document events as they occur.

Note that there are two worksheets in this Excel workbook, one for events, such as adverse events, and one for protocol deviations/violations.

The IRB strongly recommends that teams keep a running list all year long of these events, rather than trying to compile them at the last minute just before continuing review is due.

Continuing Review Assessment Sheet

The Continuing Review Assessment Sheet is designed to prompt the research team to assess all listed events to see if they indicate an increased risk or a need to amend study procedures.

Investigators will be required to complete these questions at continuing review if they are submitting a separate list of events.