Challenge # 15: Monitoring visit: Laboratory kits, What to check?

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Hello everyone! This is Vanessa Montanari from the clinical research blog for Pharmaspecific. Today we’re going to talk about a new topic. How to handle the monitoring of laboratory kits. What do you need to check for the laboratory kits ?

Text transcription :

Well, you know that in clinical trials, there are going to be tests that are going to be done, biological samples that are going to be collected, tested and to get results in the study. Sometimes the tests are done locally, that is to say in the hospital, and the laboratory will retrieve the data provided by the biology laboratory at the centre. But sometimes the data are also centralized. That is to say that the laboratory will retrieve the different samples and these samples will go to a centralized laboratory that is often abroad in order to have a standardization of data so that the data is done in a single biological biology laboratory and this laboratory will have the same standard and this will avoid differences between the different laboratories in hospitals that do not have the same standards, that do not have the same ways of functioning. Everything will be standardized thanks to the centralized laboratory in this context. The laboratory will therefore have laboratory kits, kits containing tubes that will have to be used in the context of the study. These tubes will have to be checked for a number of different things.

First of all, you’re going to have to check the expiry date on these kits, because if you’re using a kit that’s expired, it’s a bit of a problem. It could have an effect on the final result of the test. So, your test will not be usable and you will lose a data since the result will probably not be good since the kit is expired. The second thing to check is to make sure that there are enough laboratory kits for the patients in your study. For example, if you suddenly have five patients coming in for the screening visit and you only have one screening kit, you will be a little bit inconvenienced to get the tubes for the screening, since we didn’t have enough tubes. So you need enough tubes. And here then, as an ARC, you have to make sure that the necessary laboratory kits are always on site from one visit to the next and even between two visits. You make sure that there are enough kits. So what is good in some studies is that the sponsor has taken a provider who will automatically send the kits based on the patients that have been included. So it’s all a little bit connected. The patient randomization platform, the centralized lab, the CRF, it’s all connected. This means that when a patient is included, they know that additional kits have to be sent to the centre because there will be new patients and this or that kit is needed for this or that patient. So that’s convenient. But in some studies, there is no such possibility. So it’s up to you to verify that information. So it’s important to make sure there are enough kits on the site. On the other hand, there is also something else that needs to be checked. This is usually checked at the time of the selection visit, then at the time of the implementation visit and then also during the monitoring visits. You have to make sure where these kits are stored. So the kits must be in a closed place, just like the investigator binders, and no, there must be no possibility to come and touch the binders, to open them, to look at them. It must be placed in a place where a limited number of people can enter. We know who is going to come in. That’s what we’re talking about.

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