I am the study coordinator for a trial involving a drug that must be refrigerated at 2 - 8 degrees C. I have had two incidents where the temp went below this. The first time I reported this they closed the site to screening. The site got a new refrigerator and they were just about to open our site up again when the temp went below this again- it was probably less than 24 hours. I again have to damage out this very expensive drug, although they have said I can reopen for screening. The drug in question is FDA approved but just not for this use. My question is this-
Do I even want to keep this study with these extremely rigorous temperature requirements? Any suggestions? This site is an outpatient facility where constant surveillance is not possible.

Temperature control is an issue for our site as well. We have several studies with refrigerated IP and we now use 24/7 monitoring through LogTag data system which is a great tool with an alarm setting when your refrigerator gets near excursion points so you can avoid excursions.

Look at www.thedataloggerstore.com for more information

You might find that worth your time.