This document provides guidance for study teams regarding how to develop a Corrective and Preventive Action (CAPA) Plan. A CAPA is written to describe and address a deviation/noncompliance event (event) discovered during the conduct of the human subjects research study.
When a deviation/noncompliance event is discovered, study teams should take 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 are developed and implemented for more significant or systematic noncompliance, once the root cause is known. Corrective and Preventive Actions are implemented to prevent the occurrence and recurrence of an event. To avoid the need for a CAPA, study teams should have prevention and quality assurance procedures in place to proactively avoid problems. However, if a CAPA needs to be developed, the following approach will be helpful.
Identify Possible Causes: The goal of this step is to identify and document as many factors contributing to the problem as possible. There can be multiple reasons or causes that contribute to one single problem. This list may include human error, and/or process or equipment/space related factors. The focus should be on identifying underlying problems that contribute to error rather than on mistakes made by individuals.
Root cause analysis tools, including many common types of charts and graphs, can be helpful during this process. A Why Chart can be particularly helpful in determining a root cause, as it helps analyze the different layers of causes.
During the Root Cause Analysis, ask at least the following questions:
Create simple, measurable solutions that address the root cause(s). These solutions should take the form of durable corrective and preventive actions that eliminate the cause and prevent it from recurring in the future, instead of just resolving the issue at hand.
When developing a CAPA, consider at least the following:
Despite best efforts to identify root causes and solutions, the identified root causes may be incorrect and/or the solutions ineffective. Therefore, it is important that any CAPA be periodically assessed for effectiveness and modified as needed. Modifying an ineffective CAPA may require reexamining the causes of the initial event and restarting the root cause analysis process.
When monitoring a CAPA, consider at least the following:
Assistance with CAPA Development: Individuals not involved in day-to-day study conduct can provide valuable objective feedback on the potential causes of and solutions to events. It may be beneficial to engage others in your department or unit/program in this process. The Post-Approval Monitoring and FDA Regulated Research Programs are also available to provide consultation at any point during the CAPA development process.
Reporting Noncompliance: When noncompliance is discovered, submit the reportable event to the reviewing IRB as soon as possible within their required timelines as well as any other applicable oversight bodies (e.g. sponsor, FDA if the PI is sponsor-investigator). If you believe more time is necessary to conduct a full assessment of the event, contact the IRB to determine the next steps.
1 External IRBs have different noncompliance requirements. If your study was reviewed by another IRB, please follow their noncompliance requirements.