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Transcription : Hello everyone, this is Vanessa Montanari from the clinical research blog. Thank you for following us for so many years. It’s been almost 5 years that we’ve been doing articles and videos, also podcasts in clinical research.
So today, we are going to talk about the paper CRF, the electronic CRF, since someone asked me how can I present a paper CRF or an electronic CRF during an implementation?
So if you have a paper CRF. By the way, you have to be careful not to annoy the investigator too much. For that, the best is to try to present the paper CRF to him as quickly as possible, within approximately 1/4 hour. Because if he is the one who is going to fill it out, he will still have to fill it out correctly. You will thus initially present to him the various types of page; types of page compared to the various visits which there is in this CRF. You are going to introduce him to the important pages such as AE pages, concurrent treatment pages and SAE pages. So that he can see how to fill them in because if they are not filled in correctly, it will be quite embarrassing for you and you will have to ask him for corrections regularly. So, you will explain to him how to fill in those pages properly. What are the rules for filling in the CRF. So, there are some basic rules for filling in a CRF. They will be in the CRF filling guides. So, this is what you should use so that you can actually prepare this explanation for the investigator.
Then, you also tell him/her about the pages that are unusual. Often your investigator is already an investigator, not a new investigator. So, he is used to filling out CRFs and you will have to put your fingers on things that are not usual for filling out a CRF. For example, procedure pages, treatment pages. For example, these are pages that are not always present. So, you will have to tell him about those pages if you have them.
Then, if you have an electronic CRF, then it’s a little bit easier. In fact, if your electronic CRF is an CRF that is already widely used in clinical research, you won’t have a lot of work to do because you’re just going to ask, obviously well before the implementation, if the investigator is already trained in that electronic CRF if his SC is already trained in that electronic CRF and then you’re going to get his training certificates back. It has to be recent. It depends on your CRO or your pharma laboratory. So there is a time limit often 1-2 years. They have to be trained 1-2 years before they can use the CRF. Then it depends on the version of the CRF because versions change so they have to be trained on the latest version. In this case, you will just have to present during the implementation, if they have been trained, only which CRF is being used and how often it needs to be completed for example. But you won’t have to do much. But if they haven’t been trained, they will have to do the online training. So you’re either going to ask them to do it up front so that on the day of implementation they’re ready for inclusion. Then, often, the electronic CRFs are linked to randomization platforms. So in that case, you would have to explain to them how randomization is done in relation to the CRF. That is, what role the CRF has in relation to randomization, because sometimes the CRF as the platform for randomization is very connected.
So I hope this podcast has helped you and I wish you a good implementation tour and see you soon.
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