What should the investigator maintain regarding significant trial-related duties?

• A. A list of all trial personnel regardless of qualification
• B. A list of unqualified personnel
• C. A list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties
• D. A list of subjects

Answer: (C)

The important practice is maintaining a delegation log that names only those individuals who are appropriately qualified to perform significant trial-related duties and to whom those duties have been delegated. This log ensures that critical tasks—those that impact participant safety or data integrity—are carried out by people with the right education, training, and experience. It also provides a clear record of who is responsible for which duties, keeps the investigator accountable, and supports audits and inspections by showing that qualifications and responsibilities are properly matched and kept up to date. The log should be current and updated whenever duties or personnel change, and it helps verify coverage for essential tasks like consent, safety assessments, and data collection. Listing all trial personnel or only unqualified personnel, or simply listing subjects, does not guarantee that significant duties are assigned to those who are qualified or that responsibilities are traceable.