Clinical Research CoordinatorCourse 5 of 8

Clinical Research Coordinator

Full course · Participant Management: Screening to Retention

IP receipt, verification, and storage per ICH E6(R3) Annex 1, Section 2.10 — Participant Management: Screening to Retention

IP receipt, verification, and storage per ICH E6(R3) Annex 1, Section 2.10

Execute investigational product receipt, verification, and storage procedures per ICH E6(R3), establish the IP inventory log, and maintain cold chain integrity.

25 min

Every tablet, every vial, every patch — accounted for

There is a moment in the life of every clinical research coordinator when a courier arrives at the loading dock carrying a nondescript cooler or carton, and the coordinator realizes that the contents of that container represent months of pharmaceutical development, millions of dollars in manufacturing cost, and — most importantly — a treatment that a human participant is about to take based on the site's assurance that it is safe, properly stored, and correctly identified.

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.

What you will learn5 objectives

By the end of this lesson, you will be able to:

Describe the ICH E6(R3) Annex 1, Section 2.10 framework governing IP management at the investigator site
Execute a systematic shipment inspection and verification procedure upon IP receipt, including packaging integrity, labeling, quantity, and lot number confirmation
Implement storage conditions that maintain temperature requirements, restrict access to authorized personnel, and segregate IP from commercial pharmacy stock
Establish an IP inventory log that captures all required fields from the moment of receipt
Maintain cold chain integrity from shipment receipt through final placement in temperature-controlled storage

Progress saves itself — finish reading and this lesson completes

This is just the beginning

Every tablet, every vial, every patch — accounted for