Certified Clinical Research Associate (CCRA) Practice Exam 2025 – All-in-One Guide to Master Your Certification!

Question: 1 / 400

According to ICH E6, one of the primary purposes of trial monitoring is to ensure what?

The trial is completed as quickly as possible

The rights and well-being of human subjects are protected

The correct answer emphasizes that one of the primary purposes of trial monitoring is to ensure the protection of the rights and well-being of human subjects. This principle is paramount in clinical research, as the ethical conduct of studies relies heavily on safeguarding participants throughout the trial process. ICH E6 guidelines underscore the importance of respecting participants' rights, ensuring informed consent, and maintaining their safety during the study.

While completing a trial quickly or ensuring accurate data collection are important considerations, they take a backseat to the ethical obligation to protect participants. The rights and well-being of subjects must always come first, as they form the cornerstone of ethical guidelines in clinical trials. Reporting results before the conclusion of a trial is not aligned with these principles and could compromise the integrity of the research, hence why it is not considered a primary purpose of monitoring.

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Data is collected without any discrepancies

Results are reported before conclusion of the trial

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