Investigational product accountability is not a record-keeping exercise. It is a chain of custody. From the moment a shipment crosses the threshold of your site to the moment it is dispensed to a participant, returned to the sponsor, or destroyed under authorized conditions, you are responsible for proving — with documentation sufficient to satisfy a regulatory inspector — that every unit was received in acceptable condition, stored within its specified parameters, and accounted for at every step.

I have watched FDA inspectors spend more time on IP accountability logs than on almost any other document at a site. And I have seen sites fail inspections not because they lost product, but because their documentation could not prove they had not. The distinction matters enormously. In clinical research, if you cannot prove it happened, it did not happen. And if you cannot prove that IP was stored correctly, the regulator must assume it was not.

This lesson teaches the first link in the accountability chain: receiving, verifying, and storing investigational product per ICH E6(R3) Annex 1, Section 2.10.

Investigational product accountability is not a record-keeping exercise. It is a chain of custody. From the moment a shipment crosses the threshold of your site to the moment it is dispensed to a participant, returned to the sponsor, or destroyed under authorized conditions, you are responsible for proving — with documentation sufficient to satisfy a regulatory inspector — that every unit was received in acceptable condition, stored within its specified parameters, and accounted for at every step.

I have watched FDA inspectors spend more time on IP accountability logs than on almost any other document at a site. And I have seen sites fail inspections not because they lost product, but because their documentation could not prove they had not. The distinction matters enormously. In clinical research, if you cannot prove it happened, it did not happen. And if you cannot prove that IP was stored correctly, the regulator must assume it was not.

This lesson teaches the first link in the accountability chain: receiving, verifying, and storing investigational product per ICH E6(R3) Annex 1, Section 2.10.