Research Resources

Corrective and Preventative Action Plans

A Corrective and Preventive Action (CAPA) Plan ensures high-quality research by implementing good research practices. A CAPA Plan may identify the root cause of existing or potential problems, provide corrective actions, and establish a mechanism to prevent reoccurrence. Please note, a CAPA Plan is not a punishment and should not be seen as such. A successful CAPA Plan is aimed to protect the rights and welfare of animals, participants, and investigators while also ensuring reliable research data.

CAPA Plan Intake and Review Process

Researchers may submit a CAPA Plan at their own discretion, or they may be required to complete a CAPA Plan by the Office of Research Integrity and Compliance (ORIC) due to instances of non-compliance. In order to establish a CAPA Plan, please complete the following:

Intake Process

  1. Submission: Each submission should include all relevant documentation and a brief description of the existing or potential problem, including any immediate corrective and preventative actions identified.
  2. Initial Screening: Research Compliance will conduct an initial screening to ensure all relevant information is provided.
  3. Acknowledgment: Once the initial screening is complete, researchers will receive an acknowledgment email confirming receipt of their submission, along with any notice of next steps as applicable.

Review Process

  1. Detailed Review: Research Compliance reviews each submission in detail, assessing the relevance, completeness, and quality of the elements provided.
  2. Feedback and Revisions: If necessary, researchers may be asked to provide additional information or make revisions to their submissions based on the team’s feedback. Research Compliance will also coordinate reviews among other necessary offices, including the IACUC, CCM, Research Safety, and senior leadership.
  3. Final Approvals: Once all criteria are met, and all offices have provided their respective feedback, research teams are notified of the outcome.

Development of a CAPA Plan: 

  1. Corrections
    1. Corrective actions are immediately implemented upon identification of a deviation or unexpected event that may be non-compliant. The primary purpose is intended to prevent more significant deviations and/or serious non-compliance from occurring moving forward.
  2. Evaluate Risk & Root Cause Analysis
    1. After immediate corrections have been made, the Research Compliance team and the PI evaluate risks of any deviations regarding seriousness and frequency.
    2. Root cause analysis must be performed and focus on identifying underlying problems that may have contributed to an error rather than on mistakes made by individuals.
  3. Document and Implement the CAPA Plan
    1. CAPA Plans must be thorough and well documented. The plan will include information that is:
      1. Specific: Identify the actions you or others will take to address the root cause, the individual (role) responsible for taking the actions, and where you will document the actions.
      2. Timely: Include the date(s) when you or others will complete the actions.
      3. Measurable: Include a process of assessing the action plan effectiveness and a process by which the plan will be amended if it is ineffective.
    2. A thorough CAPA Plan will also include the following elements:
      1. Action type (corrective or preventive)
      2. Action description
      3. Responsible person
      4. Due date
      5. Plan for an effectiveness check
      6. Effectiveness check outcomes
  4. Evaluate (monitor) your CAPA Plan
    1. Your CAPA Plan should be monitored to ensure effectiveness. If the CAPA Plan is not effective, you should amend your CAPA plan and begin the cycle of training, implementing, and evaluating again. The Research Compliance team may assist you with the monitoring of your CAPA Plan.

It is important to remember that the primary goal of a CAPA Plan is to protect the rights, safety, and welfare of animals and researchers, while supporting compliance in your research and data integrity. For more information on CAPA Plans and other compliance needs, please contact Research Compliance.