How must delegation be documented?

How must delegation be documented?

• A. Delegation of Authority Log
• B. Written SOP
• C. Email memo
• D. Trial protocol amendment

Answer: (A)

In clinical trials, who is allowed to perform each trial-related task must be clearly recorded so there is accountability and an auditable trail. The official record for this is a Delegation of Authority Log. It names each person, their role, the specific tasks they are authorized to perform, and the dates those delegations are active. This living document stays up to date as staff change or as responsibilities shift, and it’s typically kept in the trial master file for inspectors to review. Written SOPs describe the process of delegation and the general rules, but they don’t capture who is actually authorized for which tasks at a given time. An email memo is informal and easy to lose or misfile, and a trial protocol amendment is about changes to the protocol itself, not about documenting personnel delegation. So the Delegation of Authority Log is the appropriate, durable record for documenting delegation.

In clinical trials, who is allowed to perform each trial-related task must be clearly recorded so there is accountability and an auditable trail. The official record for this is a Delegation of Authority Log. It names each person, their role, the specific tasks they are authorized to perform, and the dates those delegations are active. This living document stays up to date as staff change or as responsibilities shift, and it’s typically kept in the trial master file for inspectors to review.

Written SOPs describe the process of delegation and the general rules, but they don’t capture who is actually authorized for which tasks at a given time. An email memo is informal and easy to lose or misfile, and a trial protocol amendment is about changes to the protocol itself, not about documenting personnel delegation. So the Delegation of Authority Log is the appropriate, durable record for documenting delegation.