Which role is NOT listed as eligible to administer the investigational product at the participant's location?

• A. A healthcare professional
• B. The participant
• C. The sponsor's clinical research nurse
• D. A caregiver

Answer: (C)

The important idea is who is authorized to administer the investigational product at the participant’s location and how delegation works in GCP. Administration must be performed by individuals who are qualified and designated by the investigator, typically the site’s healthcare professionals or trained participants or caregivers under the protocol. The sponsor’s clinical research nurse is not normally eligible to administer the investigational product at a participant’s location because administration responsibilities belong to the investigator and the site team, with sponsor staff providing oversight and support rather than direct administration at the participant’s home. The other roles can be eligible when properly trained and delegated: a healthcare professional at the site, the participant themselves if self-administration is allowed by the protocol, or a caregiver who has received the required training. The key is that administration is performed by someone designated by the investigator, not by sponsor personnel.