Corrective action plans are often called for when you, or an auditor or monitor, notice a problem with a research study. The IRB may also request such a plan in response to an audit report or reportable new information submission. Corrective actions may also be appropriate for protocol deviations reported at continuing review.
When drafting corrective action plans, please note the IRB will need a complete description of how you plan to address whatever problem was identified. This language should include both a plan to fix the immediate problem, and details about how you will prevent a recurrence. Please note that simply stating the protocol requirement related to the problem will usually not be enough, and that if you limit yourself to just telling us what the protocol says should have been done (which we’ve seen quite a bit of lately), you can expect a contingency asking for more information.