Certified Clinical Research Associate (CCRA) Practice Exam 2026 – All-in-One Guide to Master Your Certification!

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What is the definition of a Biological Product?

Any drug with a marketing authorization

Any product applicable to disease prevention or treatment

The correct answer is based on the broad scope and purpose of biological products. A biological product refers to a product that is derived from living organisms and is used for the prevention, diagnosis, treatment, or cure of diseases or conditions in humans or animals. This definition encompasses a wide range of therapeutic products, including vaccines, blood components, gene therapies, and cell therapies, which are all intended to impact health by preventing or treating diseases.

The other options, while related to the context of pharmaceutical and medical products, do not encompass the comprehensive nature of biological products. Drugs with marketing authorization are not limited to biological products and can include chemical molecules. Diagnostic substances have a narrower focus and are not primarily meant for treatment, while active pharmaceutical ingredients in clinical trials refer specifically to the ingredient rather than the final product intended for patient use. Therefore, the choice indicating that a biological product is applicable to disease prevention or treatment accurately reflects its broad utility in the medical field.

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Any substance used exclusively for diagnostic purposes

Any active pharmaceutical ingredient in clinical trials

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