Delegation, Training and Your Qualifications

Part of Clinical Laboratory (LAB) Training: Foundations for the Trial Laboratory.

About 2 minutes. Free, in your language, no account needed.

The delegation log is not paperwork

Before you perform a study task, you must be delegated to perform it and trained for it. Both must be documented, and both must be dated before the work.

An inspector checks this first. It is quick to check and it fails often.

What must be in place

Your name on the delegation log, with the specific tasks you are authorized to do, a start date, and the investigator's signature.

Study-specific training, recorded. General laboratory competence is not study training. Knowing how to centrifuge is not the same as knowing this protocol's speed and duration.

A current CV and, where required, your license or certification. These support that you were qualified for the task at the time you did it.

Dates are the part that goes wrong

The most common finding is not missing delegation. It is delegation dated after the work.

If you processed samples on the 3rd and the log shows you delegated on the 10th, the record says an unauthorized person handled study samples. That is true whether or not you were competent.

Check your own date before you touch a study sample. It takes seconds.

Delegation is task-specific

Being on the log does not authorize everything. You may be delegated to receive and process but not to ship dangerous goods. Shipping frozen samples on dry ice needs separate, documented training.

Doing a task you are not delegated for creates a deviation even when you do it perfectly.

When you are asked to cover

Cover happens. Somebody is sick and samples are arriving.

If you are not delegated and trained for the task, say so before you start. The fix is usually fast, because the investigator can add and date the delegation that day.

Doing it first and correcting the log after is the version that becomes a finding.

Retraining after a change

When the protocol or laboratory manual is amended, training on the new version must be documented. Working to a superseded manual is a deviation even if you follow it perfectly.

Check the version on the manual you are holding.