Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

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Prepare for the ACRP Certified Professional Exam with our comprehensive quiz. Elevate your clinical research skills with targeted flashcards and multiple-choice questions. Enhance your readiness with detailed explanations and insights for improved performance!

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Which document outlines internationally accepted principles and practices for conducting clinical trials?

Declaration of Helsinki
ICH E6
FDA Guidelines
ISO 14155

The correct answer is: Declaration of Helsinki

The Declaration of Helsinki is a key document established by the World Medical Association that outlines ethical principles for conducting research involving human subjects. It emphasizes the importance of informed consent, the requirement for a benefit-to-risk assessment, and the necessity for ethical oversight through independent review boards. This declaration serves as a foundational guideline for researchers and ethics committees worldwide, ensuring that studies are conducted with respect for the participants' rights and welfare. While other documents like ICH E6 and ISO 14155 provide important regulatory frameworks and detailed guidelines, respectively, they tend to be more specific to the context of Good Clinical Practice (GCP) and harmonization on an international level. FDA Guidelines are specific to the United States and address regulatory compliance but do not encompass a globally accepted ethical perspective like the Declaration of Helsinki does. Therefore, the Declaration of Helsinki is essential in guiding ethical standards internationally in clinical trials.