Delegation, Qualification and the Limits of Your Authority

Part of Clinical Trial Assistant (CTA) Training: Foundations for the Trial Assistant.

About 5 minutes. Free, in your language, no account needed.

Why this matters

Every task you perform on a trial is performed because someone with authority delegated it to you, and because someone judged you qualified to do it. Both halves are recorded, and both are inspected.

If you do not know which of your tasks are formally delegated, you cannot know which of your actions are defensible.

Qualified by education, training and experience

ICH E6(R3) requires that people involved in conducting a trial are qualified by education, training and experience to perform their tasks. It does not define a qualification for a trial assistant, and there is no license for the role. What exists instead is evidence: your CV, your training record, and the delegation log entry that says which tasks you were assigned and from when.

Three things follow from that.

Your CV must be current and signed. An out-of-date CV in a site file is one of the most common and most avoidable findings at inspection, and it is often yours.

Your training record must cover the tasks you actually do, not the tasks in your job description. If you have started handling investigational product accountability records, training on that must exist and predate the first time you touched them.

The delegation log entry must precede the work. A log signed after the fact does not demonstrate delegation; it demonstrates that somebody noticed the gap.

Delegation is specific, dated and signed

The investigator delegates site tasks; the sponsor delegates sponsor tasks, often through a contract research organization. Either way the delegation is to a named person for named tasks with a start date, and it is signed by the person with authority to delegate.

Watch for two failure shapes.

Blanket delegation. "All study-related activities" delegated to everyone is not delegation; it is the absence of it. If an inspector asks who was permitted to enter data on 14 March, the log has to answer.

Drift. Roles expand quietly. You begin by filing documents, and six months later you are reconciling drug accountability. Nothing wrong happened, except that the log still says filing.

When you are asked to do something outside your delegation

Say so, immediately, and in writing. Not as an objection, as a fact: this is not on my delegation log, who should do it, and do you want me added.

That message is doing three things. It gets the task to someone permitted to do it. It creates a contemporaneous record that you identified the boundary. And it gives the delegating authority the chance to extend your delegation properly, which is often the right answer.

The wrong answer is to do it and mention it later. A task performed outside delegation is a finding whether or not it was performed correctly.

In practice

A study manager asks you, on a Friday afternoon, to complete the drug accountability reconciliation for two sites because the monitor is on leave and the sponsor wants it before Monday.

You have done reconciliations before on a previous study. You understand the work. Your delegation log on this study says document management and correspondence.

The wrong answer is to do it, because you can, and mention it at the Monday call. If an inspector later asks who performed that reconciliation and under what delegation, the answer is that an undelegated person did, and the reconciliation itself becomes questionable regardless of whether the arithmetic was right.

The right answer takes four minutes. Reply saying the task is not on your delegation log for this study, that you have performed it on other studies and are willing, and asking whether they want you added, by whom, and whether anyone else is delegated. Then wait.

Frequently the answer comes back that you should be added, the log is updated with today's date, and you do the work on Monday morning with an hour lost and the record intact. Occasionally the answer is that someone else is already delegated and nobody had noticed.

Reading your own delegation log

Most people never look at theirs after signing it. Read yours on every study at the point you join and again whenever your work changes.

Three questions. Does every task I actually perform appear on it? Does the start date precede the first time I performed each? Is anyone listed who has left, or absent who has joined?

The second question is the one that catches people. Delegation signed in March for work that began in February does not evidence delegation; it evidences that somebody noticed in March.

Key takeaways