ICH Good Clinical Practice (GCP) for Certified Clinical Research Coordinator (CCRC) Practice Exam

The key idea is ensuring clear identification and easy contact with the clinician who makes medical decisions at the site when they are not the investigator. For this person, you need enough information so anyone involved—sponsor, monitor, and IRB—knows who is authorized to make medical decisions and can reach them quickly. The required details are the clinician’s full name, professional title, practice address, and telephone numbers. This combination confirms exactly who is responsible, where they practice, and how to contact them, which is essential for medical decisions, safety reporting, and regulatory communications.

Name and contact details alone can be vague without confirming the clinician’s role and location, and license numbers, specialty, experience, or publications don’t help with timely identification or reaching the person. Therefore, including the title and address along with telephone numbers provides the complete, actionable information needed.