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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The principles and practices concerning the protection of trial subjects are derived from which guideline?

  1. ICH E5

  2. ICH E6

  3. ICH E7

  4. ICH E8

The correct answer is: ICH E6

The correct answer pertains to ICH E6, which establishes the key principles and practices regarding the protection of trial subjects involved in clinical research. ICH E6 is known as the "Good Clinical Practice" guideline, and it outlines the ethical and scientific quality standards necessary for designing, conducting, recording, and reporting clinical trials that involve human subjects. This guideline emphasizes obtaining informed consent, ensuring the confidentiality of participant data, and safeguarding the rights and welfare of trial participants throughout the research process. The focus of ICH E6 on protecting the health and rights of subjects is foundational in clinical research, making it a critical reference for researchers and regulatory authorities alike. It provides a comprehensive framework that not only governs clinical trial conduct but also fosters trust in the research process, highlighting the commitment to ethical standards and participant safety.

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