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 statement concerning trial phases is true?

  1. All phases assess efficacy in patients

  2. Phase I trials are most typical for large populations

  3. Initial administration of a drug occurs in Phase I

  4. Phase III is only concerned with toxicity

The correct answer is: Initial administration of a drug occurs in Phase I

The correct answer highlights that the initial administration of a new drug to human participants occurs during Phase I trials. Phase I trials are primarily designed to evaluate the safety, tolerability, and pharmacokinetics of a drug in a small group of participants, typically ranging from 20 to 100 healthy volunteers or patients. The primary focus at this stage is to determine how the drug behaves in the body and identify any potential side effects, thereby laying the groundwork for subsequent dosing in later phases. Understanding this context is important because while all phases of clinical trials play a role in assessing various aspects of a drug's effect, the initial exposure to the drug specifically happens during Phase I. This phase serves as a crucial step before further investigating the drug's efficacy and safety in larger populations in subsequent phases.