Which statement about delegation is true?

• A. Delegation is informal and not documented
• B. Delegation can be done without IRB approval
• C. Delegation is only for participants recruitment
• D. Delegation requires documentation and showing task and staff qualifications

Answer: (D)

Delegation means assigning trial tasks to trained staff under supervision, and in GCP this must be done formally with documentation. A delegation log is kept that shows exactly who is responsible for each task and the qualifications or training that authorize them to perform it. This setup creates clear accountability, enables traceability, and helps protect participant safety and data integrity by ensuring only qualified individuals carry out specific procedures or data-handling activities. Delegation isn’t limited to recruitment and isn’t informal or undocumented; changes to who is delegated which tasks are managed through proper training and, when needed, protocol updates or IRB notification, but the core requirement stays that the delegation is documented and the staff are qualified.