Challenge #27: My patient was enrolled, he did not have the criteria, what should I do?
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Hello everyone, this is Vanessa Montanari from the clinical research blog for Pharmaspecific. Today we’re going to look at a new topic. The patient was included when he didn’t meet the criteria. That’s something that can happen. Something that’s pretty rare, but it can happen. So, what do you have to do in this situation?
First of all, if you identify that the patient didn’t have the criteria, the first thing to do is to go to the investigator and talk to him about it. Because the patient’s safety is at stake here. So the doctor has to be able to find out and see if there’s something that can be done immediately. Then you don’t hesitate to contact the project leader and the medical monitor at the same time to inform them of this problem. You can call them by phone or send them an e-mail. However, contact them as soon as possible so that they are informed and possibly a conference call can be made if necessary. Then, what you are going to do is, once the safety period has passed, you are going to try to find solutions to prevent this from happening again in the future. A problem in the criteria may be due to a misunderstanding of the protocol by the investigator or his team. A document that has been poorly completed or a document that has been poorly done. I can give you an example. Often in the centres, the clinical study technicians prepare screening fact sheets or they may have to postpone certain criteria. If a criterion has been incorrectly reported, or there is an error in the screening form, this may have an impact on the inclusion of patients. That’s why it’s important that you, as a clinical research associate, can look at documents of this type, which the clinical study technician will prepare to help them avoid this type of error. What you can also do, if you haven’t done it yet, is to prepare a small summary, which the doctor can put in his or her pocket, so that he or she can regularly check that the criteria are being followed. That visits are made on time as part of the study. So this is something that has been done for a very long time in clinical trials. But sometimes it’s not done in some studies, and that’s something I would say is recommended to help avoid that type of error. Don’t forget, of course, to document all of this information, everything that has been said, the information in your report and in the follow-up letter that you’re going to send to the investigator.
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