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Hey Donna, Temperature monitoring and calibration planning can get tricky, especially for small sites with limited equipment and staffing. There are a few common, compliant approaches across ...

Thanks so much for your response, Rachel! That's what we used to do, but the company we've been using won't do anything involving temperatures anymore. I have contacted some local companies asking ...

Hello Donna, We have a local company come into our lab and validate all of our equipment at once: centrifuges, refrigerators, -80 freezer, thermometers, etc. We have 5 pieces of equipment calibrated ...

Hi, Great question! This comes up often and isn't always clearly explained. Per ICH GCP, only the PI is required to sign and date the protocol and any amendments to document their agreement ...

Great question! Under FDA Form 1572 requirements, you only need to list the facilities where critical clinical trial activities covered under the PI's responsibilities are performed, specifically: ...