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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Under ICH guidance, which age group is not classified as "children"?

2 to 11 years
0 to 27 days
28 days to 23 months
12 to 16-18 years

The correct answer is: 12 to 16-18 years

In the context of ICH (International Council for Harmonisation) guidelines, the classification of "children" typically refers to individuals who are not yet adults but have surpassed infancy. According to the ICH, children are generally classified into specific age categories. Infants are usually classified as individuals from birth (0 days) up to 24 months. Therefore, when considering the classifications, the age group of 12 to 16-18 years is not classified as children, as this group typically falls under the category of adolescents or youths approaching adulthood, which extends into the adult age range. Hence, this option is excluded from the definition of "children" as per ICH guidelines. The other age group options, such as 2 to 11 years and the different segments of infancy (0 to 27 days and 28 days to 23 months), are all classified under the term "children" within the ICH framework, since they refer to the younger demographic before reaching adolescence.