Who should the sponsor designate to advise on trial-related medical questions or problems?

• A. An Internal Non-Medical Staff
• B. Qualified Medical Personnel
• C. A CRO Project Manager
• D. An External Auditor

Answer: (B)

In this area, the sponsor must have someone who can provide clinical judgment on any trial-related medical questions or problems. A medically qualified person—such as a physician or other appropriately trained clinician—serves as a medical monitor or medical adviser. This role is essential to interpret adverse events, assess safety signals, advise on protocol safety concerns, and guide medical decisions that affect participant well-being. Non-medical staff can’t reliably assess clinical safety or interpret medical data, and a CRO project manager concentrates on study logistics rather than medical interpretation. An external auditor focuses on compliance and data quality, not on giving medical guidance. So, the designated individual should be a qualified medical professional who can address clinical questions with appropriate medical expertise.