International Council for Harmonisation (ICH) E6 Practice Exam 2025 - Free ICH E6 Practice Questions and Study Guide

Question: 1 / 400

What is the Declaration of Helsinki most closely associated with?

Statistical methods in clinical trials

Ethical guidelines for research involving human subjects

The Declaration of Helsinki is a crucial document formulated by the World Medical Association that outlines ethical principles for research involving human subjects. This declaration emphasizes the necessity of respecting the rights, safety, and well-being of participants in biomedical research. It serves as a foundational guideline that addresses consent, the necessity of scientific validity, and the importance of independent review, thereby ensuring that human subjects are treated ethically throughout the research process.

While other choices touch on important aspects of clinical trials and research, they do not relate directly to the core ethos of the Declaration of Helsinki, which is fundamentally about protecting human subjects and ensuring ethical conduct in research endeavors.

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A financial overview of clinical trials

Data management strategies

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