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Challenge #26 : Fraud in clinical trials, what to do?

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Good morning, everyone. This is Vanessa Montanari from the clinical research blog for Pharmaspecific. Today we’re going to look at a new topic. The consent was signed by the patient and the handwriting, for example, the date is not the same as the patient’s. In other words, you’re going to have two different handwritings, two different colours of pens that lead you to think that it’s not the patient who completed some of the information.

So what do you do when this kind of thing happens? You can be a little bit confused because you don’t expect that kind of thing. In fact it can happen, it’s quite rare, but it can happen that the information has been missed by the investigator and that someone then passes on the briefing notes. Then, the person may not pay attention and wrote it down with another pen or it’s going to be written down or it’s a different handwriting. So when you find yourself in that situation, you’re embarrassed. So the first thing to do is not to go to the investigator to tell you I think there may be fraud somewhere. The first thing to do is that you should contact your project manager to discuss it, explain what you saw and then discuss it with people above you. You can’t make this kind of decision alone and you have to wait before talking about what you’ve found. If you have any doubts, as you normally know in every company, there are procedures for managing fraud in clinical trials. So you have to use this internal procedure as well, which explains how you should proceed if you see something like this. Your role as a clinical research associate is also to be able to identify this type of thing because fraud exists. This video is very short because there’s very little that can be done about it.

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