The Chain of Custody for Investigational Product

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

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

Why this matters

Investigational product is the one thing in a trial that is simultaneously a regulated medicine, an unapproved substance, and the variable under test. The record of where every unit has been is not paperwork around the science; it is part of the science.

ICH E6(R3) places accountability for the product with the sponsor and requires the investigator to maintain records of delivery, inventory, use by participants and return or disposition. If the chain breaks, the data produced with that product becomes harder to defend.

What the chain has to show

For any unit, at any moment, the record should answer: where did it come from, where has it been, under what conditions, who held it, and where is it now.

That decomposes into shipment records with dates and quantities, receipt confirmation at the site, storage conditions monitored continuously, dispensing records linking units to participants, and return, destruction or reconciliation records at the end.

A gap anywhere means the units either side of it cannot be fully accounted for.

Temperature is part of custody, not a separate topic

Most investigational products have storage conditions, and many are shipped with continuous monitoring. A temperature excursion does not automatically make product unusable; it makes it unusable until someone qualified decides otherwise.

The correct sequence when an excursion is flagged is always the same. Quarantine the product so it cannot be dispensed. Preserve the monitoring data. Notify the sponsor and whoever makes the product decision. Wait for a written disposition. File the decision with the shipment record.

The failure is not the excursion; excursions happen in transit and nobody controls the weather. The failure is dispensing product while the question is open, or resolving it informally by phone with nothing filed.

Your part in it

You will rarely handle product. You will almost always handle the records, and often you are the person who notices that they do not agree.

Two reconciliations are worth running habitually. Shipped against received: every shipment that left has a receipt confirmation, with quantities matching. Received against dispensed plus remaining: the units on site equal what arrived minus what was used, destroyed or returned.

When those do not reconcile, the discrepancy is the finding. Do not adjust a number to make it balance. Report the difference and let the people responsible investigate it.

A worked reconciliation

A site reports 40 units received, 31 dispensed, 6 remaining. That leaves 3 unaccounted for.

The temptation is to ask the site to recount, accept a corrected figure, and move on. Do not.

Work the possibilities explicitly. Were any units damaged on receipt and quarantined separately? Were any returned by participants and not yet logged? Were any destroyed under a documented process? Were any dispensed and the dispensing record not completed? Was the received quantity actually 37, with the shipment record wrong rather than the site?

Each has a different consequence. Three units destroyed with a certificate is a documentation gap. Three units dispensed without a record is a data problem, because somebody received product and the trial cannot say who. Three units unaccounted for with no explanation is the one that must be escalated.

Why the discrepancy is the finding

The instinct to make the numbers agree is strong and it is the wrong instinct. A reconciliation that balances because someone adjusted a figure is worse than one that does not balance, because the adjustment destroys the evidence needed to find out what happened.

Record what each source says, note the difference, and escalate. The people responsible for product accountability will investigate, and the investigation is only possible if the original numbers survive.

The same applies to temperature. If the monitor says an excursion occurred and the site says the fridge was fine, both records stand and somebody qualified decides. Neither you nor the site resolves that by agreeing on a version.

Key takeaways