UUSOP-07-A: Deviations: Documentation and Reporting - Supplement A Corrective and Preventative Aaction (CAPA) Plans 

Version Date: August 13, 2025

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1. Introduction and Purpose
2. Definitions and Acronyms
3. Corrective and Preventative Action Plans
4. References
5. Revision History

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Introduction and Purpose 

Corrective and Preventative Action (CAPA) plans are critical tools used to ensure the  integrity and quality of clinical trials are maintained. CAPA plans focus on identifying and addressing the root causes of issues or non-compliance that have already occurred during the study, ensuring they are resolved to prevent recurrence.  CAPA systems help maintain the accuracy, reliability, and compliance of clinical research processes, ensuring the safety of participants, the validity of study results, and adherence to regulatory requirements. These plans are fundamental to continuous improvement and the overall success of clinical trials.

The purpose of this guidance document is to provide clarity to clinical research professionals on how to develop and implement a Corrective and Preventative Action (CAPA) plan in the context of managing issues, non-compliance, and documentation in clinical trials. 

Definitions and Acronyms 

Clinical Trial: Clinical trials are clinical research studies involving human participants assigned to an intervention in which the study is designed to evaluate the effect(s) of the intervention on the participant and the effect being evaluated is a health-related biomedical or behavioral outcome. 

Clinical Research: Clinical research includes all research involving human participants. It does not include secondary studies using existing biological specimens or data collected without identifiers or data that are publicly available. 

CAPA:	Corrective and Preventative Action
GCP:	Good Clinical Practice
NTF:	Note to File
RCA:	Root Cause Analysis
SOP:	Standard Operating Procedure

Corrective and Preventative Action Plans 

The first step in developing, maintaining, and implementing a clinical research Corrective and Preventative Action (CAPA) plan is to identify the issue—whether through review, monitoring, audit, or reporting—followed by conducting a Root Cause Analysis (RCA) to understand the underlying contributing factors. Once the root cause is determined, a detailed CAPA plan is created. The CAPA plan should outline the specific corrective actions required to resolve the issue, a timeline for implementation, and individuals responsible for each task. The plan should also include preventative measures to prevent the recurrence of the issue. After approval, the corrective actions are implemented, and their effectiveness is closely monitored through follow-up or internal reviews. Documentation is essential, and all CAPA plan activities should be recorded and maintained.  

When to Use a CAPA

• Significant Non-Compliance or Deviations: A departure from study protocols, standard operating procedures (SOPs), regulatory guidelines, or Good Clinical Practice (GCP) may indicate that a CAPA plan is needed. Deviations or instances of non-compliance that impact participant safety, data integrity, or study outcomes may also warrant a CAPA. Examples could involve issues like protocol violations, serious adverse events, drug dosing or issues with informed consent.
• Root Cause Analysis: A CAPA may be required if a substantial investigation is required to identify the underlying reasons for a deviation, recurring issue or noncompliance.
• Systemic Issues: If an issue is not an isolated incident but indicates a broader, systemic issue that could affect the overall quality or safety of the study, a CAPA plan should be developed.
• Risk of Recurrent Issues: When the risk of recurrence is high unless corrective actions are taken, and the study team needs to ensure that preventive measures are implemented to avoid future occurrences a CAPA plan may be indicated.
• Regulatory Impact: A CAPA plan may be beneficial when the identified issues could lead to regulatory scrutiny or pose a threat to the integrity of the clinical trial and its outcomes. 

CAPA Process:

1. Identification of Issue: The issue or non-compliance is identified, often during reviews, audits, monitoring visits, or self-assessments. Any identified issue or deviation should be documented in the study record as appropriate.
2. Investigation and Root Cause Analysis: A thorough investigation is conducted to understand the underlying cause of the issue. To conduct a root cause analysis, the study team should systematically identify and examine the contributing factors using structured methods such as the “5 whys”, a Fishbone Diagram or other similar processes. The “5 whys” is a common technique for performing a root cause analysis, involving the repeated questioning of why a deviation occurred- typically five times- to determine the root cause.   
3. Development: A CAPA plan is developed to address the problem or noncompliance. The plan should detail specific short term and long-term corrective actions to resolve the identified issue. Measures are put in place to prevent the recurrence of the issue, including process improvements, training, or system changes. Timelines for implementation and responsible individuals should be identified. Once a final CAPA plan has been developed, it should be shared amongst the study team for approval. 
4. Implementation: Once a CAPA plan has been approved, the study team should ensure that appropriate resources, training, or procedural changes are implemented as described. Any training that occurs due to the CAPA should be documented as appropriate.
5. Monitoring and Follow-up: The effectiveness of the CAPA is monitored over time to ensure that the corrective and preventive actions are working as intended. A follow-up review should be conducted to assess whether the corrective actions were effective in addressing the identified issue and preventing recurrence.
6. Documentation and Reporting: All records related to the CAPA must be documented and retained in study records. If necessary, a report of the CAPA should be submitted to the relevant parties, such as the IRB or study sponsor. 

Summary:

CAPA plans are used for issues that require investigation, formal correction, and action to prevent recurrence, especially those affecting study outcomes, compliance, or safety. It’s important to use this tool correctly, as CAPA plans help maintain the integrity of the clinical trial and ensure regulatory compliance. 

 

References 

• UUSOP-02 FDA Inspections
• UUSOP-07 Deviations: Documentation and Reporting

 

Revision History