Good Clinical Practice (GCP) Practice Exam

The term "investigational product" (IP) refers to a drug, device, or other product that is under investigation in a clinical trial or research study. This definition encompasses products that are not yet approved for general use and are being evaluated for their safety and efficacy in treating specific conditions or diseases. The concept of an investigational product is central to the clinical research process, as it includes all therapeutic agents being tested before they gain market approval by regulatory bodies.

In contrast to other options, a completed and marketed drug indicates that the product has already gone through the necessary studies and has received approval, thus it would not fall under the category of an investigational product. Similarly, any medication previously approved by regulatory authorities is not considered investigational if it is already being sold and used in the general population. Lastly, while a placebo can be employed during clinical trials to compare its effects with those of the investigational product, it does not encompass the broader range of possibilities included under the term investigational product.

Overall, the correct definition of an investigational product accurately reflects the nature of substances being examined for potential benefits in clinical trials, which is essential for advancing medical knowledge and therapies.