Delegation, Qualification and Your License

Part of Research Nurse (RN) Training: Foundations for the Research Nurse.

About 3 minutes. Free, in your language, no account needed.

Why this matters

On a trial you act under two authorities at once. Your nursing license, and the investigator's delegation.

Your license says what you are legally allowed to do as a nurse. The delegation log says what you are authorized to do on this study. Both must cover the task. Neither is enough alone.

Qualified by education, training and experience

ICH E6(R3) requires that everyone conducting a trial is qualified by education, training and experience for their tasks. For a nurse, that qualification is evidenced by three documents.

Your CV, current and signed. An out-of-date CV in the site file is one of the most common inspection findings, and it is usually avoidable.

Your training record, covering the tasks you actually do. Not your job title. If you started running infusions in March, infusion training must exist and predate March.

The delegation log entry, naming your tasks and the date they began. Signed by the investigator, before the work.

Delegation runs forward, never backward

A delegation log signed after the fact does not show that you were delegated. It shows that somebody noticed a gap.

If you perform a study task before your delegation is signed, that task was done without authority. The data may stand, but the deviation is real and must be recorded.

Check the log before your first study visit. It is a two-minute check that prevents a finding you cannot undo later.

Where your license limits the protocol

A protocol may ask for a task your license does not cover in your jurisdiction. Scope of practice is local. A task that is routine for a research nurse in one country may require a physician in another.

The protocol does not override your license. If the protocol asks for something outside your scope, you say so before the visit, not during it.

In practice

You are asked to obtain informed consent because the coordinator is away.

Two questions decide it. Does your jurisdiction and your license allow a nurse to take consent? And does the delegation log list consent among your delegated tasks, signed and dated before today?

If either answer is no, the answer is no. Being capable is not the same as being authorized.

What this looks like when it goes wrong

A nurse covers a colleague's visit and performs assessments she has done a hundred times. She is entirely competent. She is not on the delegation log for that study.

At the monitoring visit, every assessment she performed is questioned. Not because the clinical work was wrong, but because the record cannot show it was authorized.

The fix is a deviation report and, often, a re-review of the affected data. All of it avoidable by a signature obtained a week earlier.

Key takeaways