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Challenge # 4 The concomitant treatments are missing in the source file, what to do?

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Hello everyone !

This is Vanessa Montanari from the clinical research blog for Pharmaspecific.

Today we’re going to be looking at a new case. You have a large number of concomitant treatments in the patient’s medical records. However, not all the details are in the medical records. I mean, when I talk about all the details, you don’t have the doses, you don’t have the dose per day, how many times it’s taken per day, the start date. There is a certain amount of information missing, which makes it difficult for you to monitor your case book and to do what we call the VDS-source data verification-so, the comparison between the medical record and the case book. What do you have to do in this case?

The answer is simple, you don’t have a hundred thousand solutions. The solution you have is to offer the doctors and his clinical studies technician a pre-made chart so that he can complete all the information. That is to say that the clinical studies technician will, in this list, complete all the concomitant treatments of the patient and collect from the doctor the start dates, the end dates, the doses, the number of times the treatments were taken, the reason for taking this treatment, for which adverse events and this document will be dated and signed by the principal investigator. With this document, you will be able to do your monitoring since this document will serve as a source document. So you will have both the information in the medical file and this source document, which will be a working tool for the TEC, the investigator and for you.

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