The Patient Is In The Room. Who Is Dispensing The IP?

By Marija-Jasna Basic, Sr. CRA, PharmD, CEO Monocytes d.o.o.

Receiving the product is not the same as being ready to give it.

The first patient arrives.

The investigational product (IP) has already been delivered to the site, checked, and placed into storage. The required system steps have been completed. The team has been trained and the study has been activated.

Everything looks ready. Then someone asks a very ordinary question: Who is dispensing the IP? The answer should be obvious. Sometimes it is. Sometimes it is not.

This is where the difference between having the right things in place and being ready to use them becomes clear.

Receiving IP is only the first part of the process. Once the product is in storage, it still has to reach the right patient, in the right way, with the required checks and documentation.

The First Dose Tells You A Lot

Consider a site preparing for its first patient. The patient has arrived. The treatment assignment has been completed in IRT/RTSM. The team knows which kit is required and goes to retrieve it. Now the practical questions start:

• Who takes the kit from storage?
• Who prepares it, if preparation is required?
• Who checks the preparation?
• Who dispenses it?
• Who administers it?
• And who documents what happened?

These may sound like simple questions, but they are not always answered in the same way on paper and in practice.

The nurse who usually performs the activity may be absent. Another trained person may not have the required system access. A second person may be expected to review the preparation, but no one has clearly established who that person is.

The problem is not necessarily a lack of training. The problem is that the people, systems, and steps have not been connected into one working process.

When The Dose Was Given — But Something Is Still Missing

There is another situation that can be even more difficult to spot. The IP is prepared correctly. The required checks are made. The dose is dispensed and the patient receives the treatment. Everyone leaves the room satisfied that the job is done. Later, however, someone reviews the documentation and asks whether a required second review was completed.

If the study requires another nurse or qualified person to review the preparation and sign the appropriate record, that signature cannot be added simply because the patient received the dose. The dose was given. But one of the required steps was not documented.

The same principle applies to other study-specific controls. A successful treatment does not automatically prove that the process used to reach that treatment was completed as required. This is one reason the first dose is such a useful test of site readiness.

The IRT Screen Is Not The Whole Record

A similar issue can arise with IRT/RTSM. The system assigns a kit to the patient. The site follows the instruction, selects the kit, and dispenses it. The correct kit was used. But where is the evidence? In some studies, the site is expected to retain a printed IRT output or another defined source record showing the kit assignment. If that record is missing, the issue may not be that the wrong kit was dispensed.

The problem is that the link between the system assignment, the physical kit, and the patient has not been captured in the required documentation.

This is an easy thing to overlook because nothing went wrong during the visit. The patient received the treatment. The question appears later, when someone needs to reconstruct what happened: Which kit was assigned? Which kit was used? Where is that documented? Those questions should have straightforward answers.

What Happens When The Usual Person Is Not There?

A good way to test the process is to remove one person from it. Take the person who normally handles the IP and ask: “What happens if you are not here on Tuesday?” Who takes over? Does that person have the right training? Do they have access to IRT/RTSM? Can they retrieve the IP? Do they know what checks are required? Do they know what needs to be documented? And, importantly, does everyone else know that this is the backup arrangement?

This is often where a process that looked perfectly reasonable on paper starts to show its weaknesses. It is also why the delegation of authority log matters. It should not simply contain a collection of names and signatures. It should reflect who actually performs the study activities.

Walk The First Dose Before The Patient Does

One of the simplest ways to find these gaps is to walk through the first dose before the first patient arrives. Start with the patient coming into the clinic. Follow the treatment assignment. Identify the kit. Retrieve it from storage. Prepare it, if required. Complete the required checks. Dispense it. Administer it.

Then look at the records that should remain after the patient leaves.  Where is the kit assignment documented? Who signed the preparation review, if one is required? Who documented dispensing? What happens if the person normally doing the job is away?

It does not need to be a complicated exercise. In many cases, simply talking through the actual sequence with the people who will perform it is enough to uncover a missing step. And it is much better to find that gap before the patient arrives.

From Shipment To Patient

The IP journey starts with the shipment, but it does not end when the box is put into storage. There is a chain of people and decisions between the delivery and the patient’s dose. Each handoff matters. The courier hands the shipment to the site. The site takes responsibility for the product. Storage protects it until it is needed. IRT/RTSM provides the treatment information. The team identifies and prepares the appropriate IP. The required checks are completed. The product is dispensed and given to the patient. The records tell the story afterward.

A site may be excellent at receiving shipments and still have weaknesses further down that chain.

That is why I would not ask only, “Has the site received its IP?” I would ask: “Can the site take that IP all the way to the patient?”

The first shipment tests whether the site can receive the product. The first dose tests whether the site can actually use it. And that is where operational readiness really becomes visible.

About The Author:

Marija-Jasna Bašić is a Senior Clinical Research Associate and founder of Monocytes d.o.o., with 16 years of experience across Phase II–IV clinical trials, post-market safety studies, and medical device trials. She holds Master's degrees in Pharmacy and Medical Biochemistry from the University of Zagreb. Her unique "2-in-1" expertise combines 13 years as a Senior On-site CRA with 3 years as a Lead Central Monitor, spanning oncology, rare disease, and neurology. Through Monocytes, she delivers senior-level site management and monitoring consultancy directly to sponsors and sites, specializing in boosting site performance by identifying and preventing site-level risks before they impact data quality or timelines. She mentors junior CRAs on the CRAConnect platform and is an invited conference speaker, including at TransPerfect Life Science (London, 2025) and the CRAConnect CRA Conference (2026).