Dose Preparation, Accountability and the Record

Part of Research Nurse (RN) Training: Study Intervention Administration.

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

Why this matters

Every unit of investigational product must be accounted for. Received, dispensed, administered, returned, destroyed.

This is not stock control. It is the evidence that participants got what the data says they got.

The chain you are part of

Product arrives and is receipted. It is stored under defined conditions. It is dispensed to a named participant. Some of it is administered. Whatever is left is returned or destroyed.

You usually own the middle of that chain, and the record of the middle is the part that most often fails.

Record at the time, not at the end of the day

Write the administration record when you give the dose. Not later from memory.

Time given. Amount given. Route. Site, where relevant. Anything not given, and why.

A record written three hours later is a reconstruction. It is usually accurate and it is never verifiable, and an inspector can tell the difference from the handwriting and the timings.

Partial doses and wastage

Real infusions stop early. Vials break. Lines tissue.

Record what actually happened. If 40 millilitres of a 100 millilitre infusion were given before it was stopped, the record says that. It does not say the dose was given, and it does not say the dose was missed.

Wastage is recorded too, because the accountability must balance.

Temperature and storage

If product has been outside its storage range, it may not be usable. That decision is not yours, but the report is.

Quarantine it, do not administer it, and escalate. Product given after an unreported excursion is a problem that can reach every participant who received from that batch.

In practice

An infusion is stopped at twenty minutes because the participant reports discomfort.

You record the volume given, the time started, the time stopped, the reason, and what was done with the remainder. You also record the discomfort as an adverse event if it meets the definition.

Three records, one event, all written now.

What this looks like when it goes wrong

A site records doses as fully administered by default, and corrects the exceptions later. Most of the time there are no exceptions.

Reconciliation at close-out shows more product dispensed than can be accounted for. The site cannot reconstruct which participants had partial doses.

The shortfall is small. The uncertainty it creates is not.

Key takeaways