Challenge # 21: Centrifuge, refrigerator, freezer in clinical studies, what should you check?
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Good morning, everyone. This is Vanessa Montanari from the clinical research blog for Pharmaspecific. Today we’re going to talk about centrifuges, the refrigerator, the freezer, all those devices in which we can put biological samples in or use.
In particular, for the centrifuge centrifuge, the samples that have an impact on the clinical trial. So what I would like to say to you is that there are things you need to check about these devices. In principle, the verification is done at the screening visit. That’s when you have to set up actions with the investigator if there are problems with this equipment and then you have to check that everything is still in place at the time of setting up. Then, at the time of the monitoring, it will be necessary to have some checks done on these devices afterwards. Concerning these devices, first of all, the first thing that is important to check at the time of the selection visit is that the maintenance of these devices is carried out and that there is a maintenance contract. You simply have to ask the person in charge of these aircraft. Is maintenance being done on these aircraft and how often is it done?
This is called calibration of the device. In particular, for centrifuges, it is done every year or even every two years, depending on the device. It has to be done regularly. Then the second thing we need to see is for refrigerators and freezers. You have to make sure that the temperature is taken regularly, because if you’re asked for samples to be at minus 20 degrees, you’re going to have to be able to prove that those samples were kept at minus 20 degrees. So you need to have a probe inside that device that measures the temperature on a regular basis and that allows you to know if there has been a temperature excursion in the refrigerator or the freezer. Of course, this probe also needs to be calibrated, since it allows you to check that the temperature is adequate. But if it does not work properly because it has not been properly calibrated and there has been no maintenance on this probe, then the values you have been given will not be good. The third thing to check is to make sure that this thermometer, this probe that reads the temperature at the hospital security computer. So, the security computer, the central security station, is a place where there is security personnel, at least one person who is there 24 hours a day and who receives either fire alarms or alarms from, for example, the refrigerators in the pharmacies or any refrigerators with large samples inside. So you have to make sure that the refrigerator and freezers in your study are properly connected to this security computer so that if there is an alarm, someone can come and see what is going on and fix the problem or call the people in charge so that the samples are not lost. It would be a shame if your samples were lost because you wouldn’t have checked all of this at the selection visit. Of course, at the time of the set-up visit, you will carry out this verification. Again, you’re going to make sure that things are still in place as you found them at the selection visit. Because it can take about two months, three months, between the selection visit and the implementation visit. So you have to make sure that everything is still in place. Then, at the time of the monitoring, you will have to check that the calibration is always done on time, that the maintenance of these devices is carried out regularly and it is therefore your role as ARC to check this point. That’s it.
So thank you for following us. If you liked the program, put I like at the bottom of the video. If you want to know more about the clinical trial, you can go to the clinical research blog site. The link is here. Our CRO Pharmaspecific is a CRO specialized in clinical research, you can go to this link. Then, know that Pharmaspecific has created a white paper to help you better understand clinical studies. This is feedback from my team. It’s a guide of about a hundred pages. You can download it at the bottom of the video. Thank you very much. Goodbye.