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

Question: 1 / 400

What is the key focus of ICH E6's principles of good clinical practice?

Efficient recruitment of participants

Maximizing the financial return on investment

Ensuring data integrity and participant confidentiality

The core focus of ICH E6's principles of good clinical practice is on ensuring data integrity and participant confidentiality. This set of guidelines is designed to promote the ethical conduct of clinical trials while ensuring that the data generated is reliable and credible. ICH E6 emphasizes the necessity of safeguarding the rights, safety, and well-being of trial participants, which inherently requires maintaining confidentiality. Additionally, data integrity is paramount as it underpins the validity of trial results, ensuring that findings can be trusted and accurately reflect the study's true outcomes.

The other options, while relevant to aspects of clinical research, do not align with the foundational principles established by ICH E6. While efficient recruitment and accelerating the drug approval process are important operational considerations, they do not address the ethical and quality standards that ICH E6 seeks to uphold. Financial return on investment is a business-oriented goal that is outside the scope of the practice principles outlined in ICH E6. Thus, the emphasis on data integrity and participant confidentiality is what truly encapsulates the essence of good clinical practice in this context.

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Accelerating the drug approval process

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