Which term refers to any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product, and/or to identify adverse reactions, and/or to study absorption, distribution, metabolism, and excretion of an investigational product with the object of ascertaining its safety and/or efficacy?

• A. Confidentiality
• B. Case Report Form (CRF)
• C. Coordinating Committee
• D. Clinical Trial/Study

Answer: (D)

In ICH GCP terms, any investigation in human subjects designed to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product, and/or to identify adverse reactions, and/or to study absorption, distribution, metabolism and excretion of the product with the aim of determining safety and/or efficacy is called a clinical trial or clinical study. This term encompasses studies that assess how a new drug or biologic behaves in the body and its safety and efficacy profile, including pharmacokinetics and pharmacodynamics.

Confidentiality relates to protecting participant privacy and data; a Case Report Form is the data collection tool used during trials; a Coordinating Committee is an oversight or governance body. These terms describe components or aspects of research activity, not the investigation itself.