Corrective and Preventative Action (CAPA)
Audit Date:
Study #:
Clinical Site:
PI/treating physician:
Research Personnel:
State the deviation as it was noted in the report:
Problem/Root Cause:
Corrective and Preventative Action (CAPA):
Achievable Deadline:
Involved Personnel Signature: ______
Date:______
Direct Supervisor’s Signature: ______
Date:______
PI’s signature ______
Date: ______
All CAPAs with signatures should be e-mailed to . It is acceptable for PIs to sign a CAPA by endorsing it electronically.
Preparing a Corrective Action Plan
In preparing a CAPA for an internal audit, there are a few things to consider:
Step 1 – Clearly state the problem or weakness, including the root cause.
Define the problem. What is happening? What should be happening? How can this be fixed?
Step 2 – List the individuals who will be accountable for the result of the corrective action.
Who should be responsible? (No names; please, just list the position.) If applicable, how will they be trained to carry out their expected duties? How will they report issues or problems? When should they report problems?
Step 3 – Create simple, measurable solutions that address the root cause.
What are the regulatory requirements? What are the available resources allocated for the study? What can be reasonably accomplished?
Step 4 – Each solution should have a person who is accountable for it.
Should one person be solely accountable? Should two people share the responsibility? Should there be a segregation of duties?
Step 5 – Set achievable deadlines.
Who many people are dedicated to the effort (consent, be in clinic, order test, enter data, and follow up with patient, etc.)? Does an external entity need to sign off on the changes (pharmacy, radiology, RT, etc.)? What is a reasonable time frame to develop or train?
Step 6 – Monitor the progress of your plan.
When will supporting documentation be needed? At the next audit? At the next DMC? At the time of semi-annual reporting?
Non-compliance requires corrective action planning to address the deficiencies. The corrective action plan should include more than just the identification of the deficiency and intervention chosen to address the issue. Effective corrective action planning includes other important components that lead to promoting improved performance for future activities: ultimately improved human subject protections and data integrity.
One major deviation or 3 lesser deviationsusually require a written corrective plan and interim re-audit. Please submit your CAPA to the noted violations via email to by the specified date.
With your help in completing the items described above, we can all work together to make the audit process efficient, accurate, effective, and easy. We appreciate your effort!
V 07Oct20141