When a deviation/noncompliance event is discovered, immediate measures (also referred to as corrections) to mitigate risk and protect rights, safety, and welfare of the subject(s) and others should be taken. This may be in the form of a phone call or an office/clinic visit between the subject and a member of the research team, or other tests and procedures to ensure the subject’s safety. Corrections alone may resolve minor deviations, but they will not effectively resolve more significant or systematic noncompliance, which generally also require corrective and preventive action.

Corrective and Preventive Actions (CAPA) are developed and implemented for more significant or systematic noncompliance, once the root cause is known. CAPA are implemented to prevent the occurrence and recurrence of an event. For more information on CAPAs, see the Post-Approval Monitoring Program’s website.