Certified Clinical Research Associate (CCRA) Practice Exam

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Prepare for the CCRA Exam with interactive flashcards and multiple choice questions, each offering hints and detailed explanations. Equip yourself with the knowledge you need for certification success!

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What is the purpose of the ICH Harmonised Tripartite Guideline E11?

To discuss adult clinical trials only
To regulate international health organizations
To facilitate pediatric medicinal product development
To set guidelines for medical device testing

The correct answer is: To facilitate pediatric medicinal product development

The ICH Harmonised Tripartite Guideline E11 is specifically designed to facilitate the development of pediatric medicinal products. This guideline addresses the unique challenges associated with conducting clinical trials in children and emphasizes the importance of gathering data on safety and efficacy for pediatric populations. It encourages the inclusion of pediatric assessments early in the drug development process, which is crucial since children's responses to medications can differ significantly from adults due to developmental and physiological differences. The guideline also provides recommendations on study design, ethical considerations, and the need for age-appropriate formulations. This focus on pediatric populations is essential to ensure that medicines are effective and safe for children, helping to bridge the gap in clinical evidence that has historically existed in this demographic. Other options are not relevant as the guideline is not limited to adult clinical trials, does not deal with regulatory matters for health organizations, nor does it provide design specifications for medical device testing. The overall aim of Guideline E11 is to ensure that children are appropriately represented in medicinal product clinical trials, thereby enhancing pediatric healthcare outcomes.