A Corrective and Preventive Action Plan (CAPA) ensures high-quality research by implementing good research practices. The CAPA Plan should identify the root cause of existing or potential problems, provide corrective actions, and establish a mechanism to prevent reoccurrence. A successful CAPA can protect the rights and welfare of animals, participants, and researchers and ensure reliable data. CAPA plan should be submitted as non-compliance PI Self-report, as a results of PAM findings, or external audit/inspection. If the CAPA plan submission is a PI self-report or as a result of PAM findings, the CAPA plan needs to be submitted along with the Reportable Events and New Information (RENI) form to the regulatory committee. This is mandatory for any major deviations and/or (if applicable) Unanticipated Problems (UPs) identified in the conduct of a study. When submitting a CAPA plan resulting from an external audit/inspection, it is important to follow the guidelines provided by the auditors. It is also necessary to include any required forms and send a copy of the plan to the regulatory committee via email. In some cases, the external auditor may provide their own CAPA form to replace the standard one.

For CAPA plan in Clinical Research, please use the forms and instructions from the Office of Clinical Research.

For the CAPA plan in IACUC, IBC, or IRB in non-clinical research or Social, Behavioral, or Education Research (SBER), please read the CAPA Standard Operation Procedures (SOP) and complete the CAPA form. Please submit the form to the respective regulatory committee via email.

• CAPA SOP
• CAPA Form
• Reportable Events and New Information (RENI) Form

CAPA Submission:

• IACUC – iacuc@utrgv.edu
• IBC – ibc@utrgv.edu
• IRB – irb@utrgv.edu