How are activities allocated between sponsors and investigators?

• A. Investigators perform all activities.
• B. Regulatory bodies allocate all activities.
• C. Activities are allocated based on expertise, responsibilities, and regulatory requirements.
• D. Sponsors perform no activities.

Answer: (C)

Activities in a clinical trial are allocated to the party best positioned to perform them safely and in compliance with laws and guidelines, based on expertise, defined responsibilities, and regulatory requirements. The sponsor holds overall responsibility for the trial—design, funding, selecting investigators, ensuring protocol compliance, proper oversight and monitoring, and timely safety reporting to regulators and ethics committees. Investigators at the site conduct the study per the protocol, obtain informed consent, protect participant safety, ensure accurate data collection and records, and report adverse events. This division of labor ensures that each task is handled by those with the appropriate qualifications and regulatory duties, supporting participant protection and data integrity. The other options imply one party handles everything or none of the activities, which does not align with how GCP assigns responsibilities.