What best defines sponsor-investigator responsibility?

• A. The individual who initiates and conducts the trial and ensures compliance with GCP and regulations.
• B. Institutional review board
• C. Data manager
• D. Clinical research coordinator

Answer: (A)

Sponsor-investigator is the person who both initiates and conducts the trial and ensures compliance with GCP and regulations. This combined role carries the sponsor’s oversight duties (regulatory submissions, safety reporting, trial monitoring, and ensuring overall compliance) along with the investigator duties (conducting the study per protocol, obtaining informed consent, protecting participants, and maintaining data integrity). The other roles—IRB protecting participant rights, data manager handling data tasks, and clinical research coordinator supporting operations—do not carry this full set of sponsor-level and investigative responsibilities.