What is an Investigational Product?

Prepare for the CITI Good Clinical Practice (GCP) Exam with comprehensive questions, hints, and explanations. Master the essential concepts to excel in your exam!

An Investigational Product refers specifically to any unapproved drug, device, or biologic that is being tested in clinical trials to evaluate its safety, efficacy, or other characteristics. This definition encompasses a wide range of products that are not yet approved by regulatory authorities for general use. The focus on products that are still under investigation emphasizes their potential for becoming approved treatments or therapies, pending the results of clinical studies.

The other options highlight different classifications of products, but they do not accurately define an Investigational Product. For instance, a product that has received FDA approval signifies that it has completed the necessary clinical trials and can be marketed to the public, thus not qualifying as "investigational." A commercially available pharmaceutical is also beyond the investigational phase, as it is already on the market. Lastly, a product used solely for educational purposes does not align with the concept of an investigational product, which is specifically tied to the clinical trial context and aims to gather data for potential therapeutic use. Overall, the definition provided in the correct choice captures the essence of products that are exploring their role in healthcare through ongoing research.

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