Who is accountable / responsible for left over clinical supplies and disposal / destruction of them? Is proof of destruction necessary for PI / sponsor?
CHP – I am sure you know how I would respond to this. The PI is responsible for all aspects of any clinical Study including the left over clinical supplies. These supplies are disposed of according to either the protocol or the agreement with the sponsor of the study. The Clinical Pharmacology Unit (CPU) would most likely have an SOP regarding the disposal and/or destruction of left over drug supplies including the retaining of a sample of each lot. Not sure what you mean by “Proof” but if honor, integrity and honesty define the PI / CRO, this should not be an issue.
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