Which term is a person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions?

• A. Contract Research Organization (CRO)
• B. Coordinating Committee
• C. Confidentiality
• D. Clinical Trial/Study

Answer: (A)

Outsourcing trial work to an external party contracted by the sponsor is a common setup in clinical research. This term describes a person or organization—such as a company—hired to perform one or more of the sponsor’s trial-related duties and functions. A CRO might handle activities like site monitoring, data management, statistical analysis, safety reporting, and regulatory submissions. The sponsor writes the contract and scope of work, but the CRO carries out the tasks under the sponsor’s oversight. Even though the work is delegated, the sponsor remains responsible for the trial’s integrity, participant safety, and compliance with GCP.

The other options don’t fit because a coordinating committee is just a group that helps coordinate activities; confidentiality is a protection of information, not a service provider; and a clinical trial/study is the research project itself, not the party performing outsourced duties.