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Compliance In Focus
Posted by Brad Lieberman on Thu, Oct 15, 2020

Why Do You Need A CAPA Process?

A corrective and preventive action (CAPA) process can help address three possibilities we all fear in clinical trials:


  1. A patient’s safety, rights, or wellbeing is put at risk
  2. The study data is compromised or incomplete
  3. There are findings or even a warning letter that result from an FDA inspection

If a fire that has the potential to spread is caught early, then it can be extinguished before it gets out of control. In clinical research, a problem resulting in the above possibilities has the potential to increase in severity or become more widespread if it’s related to a process. This is when a CAPA process is especially valuable.

Here’s a closer look at what situations call for a CAPA process and what yours should include.

When Is A CAPA Process Necessary?

Not every protocol deviation, IRB policy violation, or even non-compliance with a regulation is the result of a poor process. A corrective and preventative action plan (CAPA) should be utilized when there is a process-level issue, especially if the issue is serious, if there are multiple occurrences, or if it has the potential to spread.

Well-designed quality management systems, standard operating procedures (SOPs) and risk management plans can help sponsors and sites determine whether and when a CAPA should be issued.

FDA regulations (21 CFR Parts 312 and 812) indicate that sites need to be compliant with the regulations, 1572/agreements, investigational plan, and requirements of the IRB, and that sponsors must secure compliance. Lower rates of compliance can result in findings at a regulatory inspection, but providing an FDA investigator with documentation of efforts to increase compliance may either decrease the severity of the findings or potentially result in no findings.

A CAPA is an essential risk-based tool for continuous improvement and moving ever closer towards full compliance.

What Should Your CAPA Process Include?

A good CAPA process involves three fundamental steps:

  1. Investigating the problem and determining the root cause
  2. Writing a comprehensive CAPA
  3. Implementing the CAPA and verifying the actions taken are adequate

1. Determining the Root Cause

A root cause analysis is a set of techniques to identify the underlying reason for what happened. There are several different strategies for conducting a root cause analysis.

One approach is to ask why something occurred in multiple ways until you identify the cause. This is known as the Five Whys.

Here’s an example of how you might use this approach to determine why informed consent was obtained using an outdated version of the form.

Question: Why did the subjects sign an old version of the form?

Answer: There was a stack of previous versions in the research office.

Question: Why was there a stack of previous versions in the research office?

Answer: No one printed the new version and replaced the old one.

Question: Why didn’t anyone print the new version?

Answer: The research coordinator who had access to the IRB website containing newly approved informed consent forms was on vacation.

You can continue this line of questioning until you arrive at the underlying cause. In this case, it was the fact that only one person had access to the IRB portal, and that person happened to be out of the office.

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2. Writing A Comprehensive CAPA

A well-written corrective and preventive action plan is detailed and thorough, yet concise. It includes several key pieces of information:

  • A detailed narrative of what occurred
  • A summary of the investigation and root cause analysis
  • A description of the root cause
  • A detailed list of corrective and preventive actions and a plan for implementing them

It should also include signature lines for the principal investigator, research coordinator, quality assurance manager and any other key personnel.

3. Implementation and verification

Your CAPA process doesn’t end with documentation. You’ll need to ensure you share your plan with the appropriate parties, train them as necessary and establish a timeline for other actions.

When all actions have been implemented, you can consider your CAPA process complete. You may want to schedule a closing meeting to ensure you’ve followed all the steps you originally outlined.

For more guidance on each step of the CAPA process and templates for writing effective plans, download our CAPA whitepaper.


Topics: CAPA


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