Shipments, Customs and Things That Do Not Arrive

Part of Clinical Trial Assistant (CTA) Training: Investigational Product Logistics.

About 4 minutes. Free, in your language, no account needed.

Why this matters

A shipment is not complete when it is despatched. It is complete when a qualified person at the receiving site has confirmed receipt, quantity and condition, and the record says so.

The gap between those two states is where most product problems live, and it is almost always your job to watch it.

Before anything ships

Confirm the site is authorized to receive. That means activated, with product handling arrangements in place and the pharmacy or designated holder identified.

Confirm the destination details are current. Sites move, pharmacies change, and a delivery to a locked loading bay at 17:30 on a Friday will sit at ambient temperature all weekend.

Confirm the paperwork the border needs. Where product crosses a customs boundary the import license, the shipping documentation and any language requirements are as much a part of the shipment as the product.

When it does not arrive

The question to answer first is always the same: where is it now, and what temperature has it been.

Everything else follows from that. A shipment stalled in customs at controlled temperature is a schedule problem. The same shipment sitting on an unrefrigerated dock is a product problem, and the clock is running.

Work the two in parallel. Get someone chasing physical location through the courier and the broker, and simultaneously get the monitoring data pulled so that whoever makes the disposition decision has it ready.

Tell the site early, even before you know the answer. A site that learns on the day of a scheduled dosing visit that product will not arrive has lost a participant visit and some trust. A site told three days earlier can reschedule.

Customs is a predictable problem

Delays at borders are so common they should be planned for rather than reacted to. The recurring causes are documentation mismatches between the invoice and the license, missing or expired import permits, public holidays that differ between origin and destination, and product descriptions that invite inspection.

Learn the pattern for the countries your study ships to. A study running in five countries has five different pattern sets, and the one that catches people is the assumption that the process that worked in one applies in another.

Do not let a delivery problem become a data problem

The pressure when a shipment is late is to find a workaround. Borrowing product from another site, dispensing from a quarantined lot, or using expired units are all things that have happened under pressure and all are worse than a missed visit.

A missed visit is a protocol deviation that gets documented. Dispensing unaccountable product is a problem with the data.

A worked incident

A shipment to a site in Nairobi was due Tuesday. On Wednesday it has not arrived and the site has a participant scheduled to dose on Friday.

Hour one. Establish location and temperature. The courier portal shows it held at the airport since Monday evening. The data logger is in the shipment and cannot be read remotely, which means the temperature history is unknown until it is opened.

Hour two. Two parallel tracks. Ask the broker what is holding it, which turns out to be a mismatch between the commercial invoice value and the import permit. And tell the site now, so Friday can be rescheduled inside the protocol window if needed rather than missed.

Day two. The paperwork is corrected and the shipment clears. On arrival the logger shows eleven hours above the upper limit.

What happens next is the part that matters. The product is quarantined on receipt, not dispensed. The logger data goes to the sponsor. A qualified person makes a written disposition decision. Only then does the product become usable or not.

The participant's Friday visit moves to the following Tuesday, inside the window, documented. No deviation, no compromised product, and a shipment record that tells the whole story.

The version of this that goes wrong

The same incident, handled by pressure: the product arrives Friday morning, the excursion is noticed, somebody calls the sponsor and is told verbally it is probably fine, and the participant is dosed.

Nothing may be wrong with the product. But the trial now has a participant dosed with material whose disposition was never documented, and there is no way to construct that evidence afterwards.

Key takeaways