Which document records who is authorized to perform specific trial tasks?

Which document records who is authorized to perform specific trial tasks?

• A. Informed Consent Document
• B. Sponsor Agreement
• C. Investigator's Brochure
• D. Delegation of Authority Log

Answer: (D)

The key concept here is documenting who is authorized to perform specific trial tasks. A Delegation of Authority Log records, for each task, which individuals are permitted to perform it and when that authorization is in effect. This creates clear accountability and helps ensure that only trained and qualified personnel carry out protocol-required activities—such as obtaining consent, performing procedures, entering data, or handling safety reporting. The log should be kept up to date whenever staff changes or new responsibilities are assigned, and it’s a primary reference during monitoring and inspections. By contrast, the Informed Consent Document explains to participants what they’re agreeing to and records their consent; the Sponsor Agreement outlines contractual terms between sponsor and site; and the Investigator's Brochure provides background on the investigational product and study design. None of these specify who is authorized to perform specific trial tasks the way a Delegation of Authority Log does.

The key concept here is documenting who is authorized to perform specific trial tasks. A Delegation of Authority Log records, for each task, which individuals are permitted to perform it and when that authorization is in effect. This creates clear accountability and helps ensure that only trained and qualified personnel carry out protocol-required activities—such as obtaining consent, performing procedures, entering data, or handling safety reporting. The log should be kept up to date whenever staff changes or new responsibilities are assigned, and it’s a primary reference during monitoring and inspections.

By contrast, the Informed Consent Document explains to participants what they’re agreeing to and records their consent; the Sponsor Agreement outlines contractual terms between sponsor and site; and the Investigator's Brochure provides background on the investigational product and study design. None of these specify who is authorized to perform specific trial tasks the way a Delegation of Authority Log does.