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A site has reported multiple temperature excursions for an IP, primarily because the air conditioning...

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A site has reported multiple temperature excursions for an IP, primarily because the air conditioning (A/C) gets shut off after business hours. A separate A/C unit cannot be installed in the room where the IP is kept. What would be the MOST effective long-term mitigation strategy?

A.

Return all IP and request the CRO/Sponsor to directly ship IP to participants.

B.

Invest in a room temperature controlled IP cabinet and transfer IP to this unit.

C.

Continue reporting temperature excursions per the pharmacy manual guidelines.

D.

Install an air cooler requiring regular water refills to maintain the room temperature.

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