No matter your role in clinical research, you may encounter issues that require further investigation.
For instance, imagine you realize two medical devices are missing. You eventually find them, but in the meantime you're concerned they could have been accidentally implanted into patients who were not study participants.
Anytime you encounter a serious process-level issue, you should investigate the cause and create a corrective and preventive action plan, known as a CAPA.
What Is A CAPA?
A CAPA is a clear, concise and comprehensive document.
A well-written CAPA should include:
- A brief summary of the problem
- A detailed narrative of what occurred
- A summary of the investigation and root cause analysis strategy
- A description of the root cause
- Corrections that are needed to remediate the problem
- A detailed explanation of the corrective actions you plan to take
- A detailed explanation of preventive actions
- Your plan for implementing your CAPA
While one person may be tasked with writing your CAPA, it should have input from all stakeholders, such as your principal investigators, research coordinators, project managers, CRAs and quality assurance personnel.
How Do We Implement A CAPA?
Writing your CAPA is only the beginning. Once you have your CAPA in place, there are several steps you can take to successfully implement it. A few basic strategies include:
- Sharing it with appropriate parties
- Scheduling a training session with the individuals involved
- Establishing a timeline for each corrective and preventive action
- Scheduling regular meetings with those involved to get an update on the status of each CAPA
Although creating and implementing a CAPA may seem daunting, it's an important part of holding clinical research personnel accountable, protecting patients and ensuring compliance.
Need help with your CAPA? Download our guide to conducting a root cause analysis, writing a comprehensive CAPA and implementing it.
You'll get a detailed overview of when and how to write a CAPA, as well as templates and examples.
And if you have more questions, our team is always here to help.
