The Shipment That Goes to a Door

Part of Decentralized Trials (DCT) Training: Direct-to-Participant Shipping.

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

Accountability does not stop at the doorstep

Every unit of investigational product must be accounted for from receipt to destruction. That requirement does not change because the product went to a home.

What changes is that the chain runs through a courier and a participant, neither of whom is trained in accountability.

Know the chain for every shipment

Where it shipped from, when, by whom, under what conditions, to what address, and who signed.

If any of those is unknown, the chain has a gap, and the gap is in your record rather than in the courier's.

The address is a data quality problem

Wrong addresses are common and expensive. A participant who moved, a typo, a delivery to a neighbor.

Confirm the address before each shipment rather than relying on the enrollment record.

Signature does not mean the participant received it

Couriers accept signatures from whoever is at the door. A shipment signed for by a neighbor is delivered and not received.

Confirm receipt with the participant directly, and record that confirmation as a separate fact from the delivery.

Temperature applies in transit and at home

A product requiring cold storage needs a validated shipper and a home storage instruction the participant can actually follow.

"Keep it in the fridge" is not a controlled condition. If the study needs monitoring, the participant needs a device and an instruction, and you need the reading.

An undelivered shipment is urgent

Missed doses start immediately. Track shipments actively rather than waiting for the participant to report that nothing arrived.

Record what the participant was told

Storage, handling, what to do if the packaging is damaged, and who to call. Those instructions are part of accountability, because the participant is now the custodian.