A sponsor conducts a risk assessment and decides to centralize IP dispensing at a pharmacy hub rather than each site. This approach is best described as:
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A
A protocol amendment requiring full IRB re-review
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B
Centralized IP management, permissible when validated and compliant with local regulations
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C
A GCP violation because IP must be stored at the investigator site
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D
An FDA prohibited practice under 21 CFR 312