Certified Clinical Research Coordinator (CCRC) Complete Practice Exam 2025

In clinical research, an "Investigational Product" refers specifically to a product that is currently being tested for safety and efficacy but has not yet received regulatory approval for general use. This encompasses new medications, devices, or biologics that are undergoing evaluation in clinical trials to determine their therapeutic relevance, dosage, and potential side effects.

This term captures the essence of the clinical research process, where the primary purpose is to gather the necessary data to ensure that a product can eventually be made available to the public once it has been demonstrated to meet the required standards of effectiveness and safety.

The other options represent contrasting scenarios where the definition does not hold. For instance, a new medication that has been approved no longer qualifies as an investigational product because it is now available on the market. A placebo is a control used in clinical trials, not an investigational product itself. Finally, a marketed product that is referenced indicates that it is already approved and being sold, again not falling under the category of being investigational. Thus, the appropriate definition of an "Investigational Product" is indeed one that is being tested but not yet approved for widespread use.