Good Clinical Practice (GCP)
Full course · ICH E6(R3) Principles
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Learn how ICH E6(R3) establishes comprehensive requirements for investigational product manufacturing, handling, storage, and documentation to ensure participant safety and trial integrity.
In a Phase III cardiovascular trial, a site pharmacy received a shipment of investigational product on a Friday afternoon. The receiving technician noticed the temperature monitor indicated the shipment had exceeded the upper storage limit during transit, but the excursion was brief—only 42 minutes above threshold. Uncertain whether this mattered, and with the pharmacist already gone for the weekend, the technician logged the shipment into inventory and placed it in the storage unit. The following Monday, when the pharmacist reviewed the records, the affected units had already been dispensed to three participants.
This scenario, which plays out in variations across research sites worldwide, illustrates why investigational product management receives its own principle in ICH E6(R3). The investigational product is, in a very real sense, what the trial is about. Every protocol procedure, every data point, every safety assessment ultimately connects to a simple question: Does this product work, and is it safe? If the product itself is compromised—through manufacturing defects, handling errors, or degradation—the trial cannot answer that question reliably. And more immediately, participants may be exposed to products that are ineffective or harmful in ways unrelated to the product's inherent properties.
Principle 11 establishes that investigational products must be manufactured according to Good Manufacturing Practice standards and handled throughout the trial in ways that protect their integrity. This is not merely a logistical requirement. It is fundamental to both participant safety and the scientific validity of the research.
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