Which term is an investigational or marketed product, or placebo, used as a reference in a clinical trial?

Prepare for the ICH Good Clinical Practice (GCP) Exam for Certified Clinical Research Coordinator with engaging multiple-choice questions and detailed explanations. Elevate your understanding and expertise to excel in your certification exam!

Multiple Choice

Which term is an investigational or marketed product, or placebo, used as a reference in a clinical trial?

Explanation:
In a trial, you need a reference to compare against the new intervention. That reference product is called the comparator (Product). It can be an active treatment, a marketed product already in use, or a placebo, depending on the study design. The comparator provides the baseline that allows you to judge whether the investigational product has any added benefit or risk. Confidentiality relates to protecting participant data, contracts govern agreements, and a coordinating investigator is a site leadership role. None of these describe the reference product used for comparison in a trial.

In a trial, you need a reference to compare against the new intervention. That reference product is called the comparator (Product). It can be an active treatment, a marketed product already in use, or a placebo, depending on the study design. The comparator provides the baseline that allows you to judge whether the investigational product has any added benefit or risk.

Confidentiality relates to protecting participant data, contracts govern agreements, and a coordinating investigator is a site leadership role. None of these describe the reference product used for comparison in a trial.

Subscribe

Get the latest from Passetra

You can unsubscribe at any time. Read our privacy policy