SOCRA CCRP Practice Exam

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Which of the following is part of the CAPA process?

Recruitment of new trial participants
Data mining for statistical significance
Identification of root cause of issues
Publishing of trial results

The correct answer is: Identification of root cause of issues

The CAPA process (Corrective and Preventive Action) is a systematic approach to identifying, investigating, and addressing issues or non-conformities within a system or process. This process involves identifying the root cause of the issue, implementing corrective and preventive actions, and verifying their effectiveness. In this case, options A and D are incorrect because they do not involve addressing issues or non-conformities. Option B is incorrect because data mining is not a part of the CAPA process. Only option C, identification of root cause of issues, aligns with the definition and purpose of the CAPA process.