If your clinical research site has experienced serious process-level issues, a corrective and preventive action (CAPA) plan can help.
A CAPA is a formal, documented process for making improvements and moving closer toward compliance.
The first step in the CAPA process is to thoroughly investigate the problem and determine the root cause.
Once you've done that, the next step is to write a comprehensive plan summarizing the issue and how you will avoid it in the future.
A well-written CAPA is detailed, yet concise.
If you've never written one before, this CAPA example checklist is a good place to start.
Once you have completed your CAPA, you'll want to share it with everyone who will be involved in implementing corrective and preventive actions and establish a timeline.
After you've taken all the necessary actions, you can consider your CAPA process complete.
If you have experienced serious issues at your clinical research sites, IMARC can get you back on track with monitoring, auditing, training, and more.