Your IP Shipment Arrives At 07:00. Who Opens The Box?

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

Training complete does not always mean operationally ready.

The courier arrives at 07:00 with investigational product (IP). The person at the site is ready to receive the shipment. The courier provides the shipment and the relevant transport temperature records. The site checks them, everything appears to be within the required conditions, and the shipment is accepted. The courier leaves.

Then someone asks: Who confirms the receipt in IRT?

The person who received the shipment does not have IRT access. Someone else has access but is not at the site yet. At the same time, the IP needs to move into the required storage conditions, and the site’s storage-temperature monitoring needs to start without a gap.

Nothing was necessarily wrong with the shipment. The weakness was in the handoff.

For clinical supply teams, this is an important distinction. A site can be fully trained, have the right documents in place, and still not be operationally ready to receive IP.

IP Receipt Is A Chain Of Handoffs

From the supply chain perspective, an IP shipment does not simply move from a depot to a site and become “received.” Several activities take place during that transition, and each one needs to connect to the next.

The site first needs to establish that the shipment arrived in the expected condition, including the applicable transport temperature information. That transport temperature information then needs to be uploaded or confirmed in the required system, according to the study process.

Once the site accepts the IP, responsibility for the product at the site begins. The product needs to move into the appropriate storage conditions, and the site’s required storage-temperature monitoring needs to begin without a gap. There may also be an IRT/RTSM receipt confirmation to complete.

These activities are closely connected, but they are not interchangeable. The incoming temperature information tells the site what happened during transport. The system step creates the required record of that information. Site storage and temperature monitoring then control what happens to the IP after the product is under the site’s responsibility. A gap between any of these steps can turn a straightforward delivery into an operational issue.

The Temperature Story Does Not End When The Courier Leaves

Temperature control is a good example of why operational readiness needs to be considered as a process rather than a checklist item.

A site may correctly review the transport temperature information and confirm that the shipment arrived within the required conditions. That is important, but it does not complete the site’s temperature responsibility.

The transport information may still need to be uploaded or confirmed in the relevant system. Then, once the site accepts the IP, the product needs to move into its required storage conditions and the site’s own temperature monitoring needs to take over as required.

The handoff between those activities matters. There should not be an assumed period in which everyone believes someone else is responsible. The courier has left. The IP is now at the site. Who owns it? That question should already have an answer.

The Same Applies To IRT

The 07:00 scenario also exposes another common disconnect. The person receiving the shipment may be appropriately delegated to receive IP. That is good. But does that person have the required IRT access to confirm receipt? If not, who performs that step? If the answer is “someone from the study team will do it later,” the site may technically have all the necessary people and systems, but the operational handoff has not been designed.

The same problem can occur in the opposite direction. A person may have IRT access but not be the person delegated to receive the IP. Neither situation necessarily means that the site lacks the required resources. It means that the resources have not been connected into one workable process. That is an important difference.

Readiness Is More Than Having The Right Names On Paper

Clinical supply teams are accustomed to checking whether required elements are in place: training, delegation, system access, storage arrangements, temperature monitoring, and documentation. Those checks remain necessary. But a stronger readiness question is: Do these elements work together at the moment the shipment arrives?

Consider what happens if the primary person is unexpectedly unavailable.

• Who receives the IP?
• Who checks the transport temperature information?
• Who ensures the information is uploaded or confirmed as required?
• Who moves the IP into storage?
• Who is responsible for the site’s required temperature monitoring?
• Who confirms receipt in IRT?
• And can the backup person actually perform those activities?

A site may have a backup listed in a document. That does not necessarily mean the backup is operationally ready. They may not have the required system access. Their delegation may not cover the relevant activity. Or they may never have walked through the process themselves. The gap only becomes visible when the shipment arrives.

Walk The Process Before The Shipment Does

One of the most useful readiness exercises is also one of the simplest: walk through an actual shipment before the first delivery. Start with the courier arriving at the site.

• Who receives the shipment?
• What does that person check?
• What happens with the transport temperature information?
• Where is it recorded or confirmed?
• Who ensures the IP reaches the appropriate storage conditions?
• When does the site’s required temperature monitoring begin?
• Who confirms receipt in IRT/RTSM?
• If those steps involve different people, how does the handoff happen?
• Then remove the primary person from the scenario.
• What happens if they are on leave?
• What happens if they are delayed?
• What happens if the shipment arrives earlier than expected?

The objective is not to create another document. It is to see whether the process can operate without improvisation.

The Small Gaps Are Often The Important Ones

A missed shipment window is obvious. A temperature excursion is obvious. A shipment that cannot be located is obvious. The more difficult problems can be much smaller.

The right person receives the shipment but cannot complete the system step. The transport temperature is checked but the required system confirmation happens later. The IP is accepted but responsibility for storage temperature monitoring is unclear. The backup exists but cannot actually perform the activity.

Each individual issue may appear manageable.

But clinical supply execution depends on these small handoffs working consistently. When they do not, the site becomes dependent on phone calls, reminders, escalations, and individual knowledge to keep a routine shipment moving.

That is not the same as having a resilient process. The certificate is evidence. The process is the test. Training certificates matter. Delegation matters. IRT access matters. Temperature monitoring matters. Documentation matters. But each is only one part of the readiness picture. The real test is what happens when the courier arrives at 07:00.

Can the site receive the IP, verify the incoming transport conditions, complete the required system steps, move the product into the appropriate storage conditions, and take over the required temperature monitoring — with clear ownership at every handoff?

If yes, the site is demonstrating operational readiness.

If the team needs to stop and work out who has access, who is delegated, who monitors the temperature or who owns the next step, the gap was already there. The shipment simply exposed it. For clinical supply professionals, that distinction is worth paying attention to.

A shipment can be delivered successfully and the site can still be operationally unready. The courier’s job ends at delivery. The site’s readiness begins there.

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).