Challenge #6 My patient’s medical record is lost! What can I 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. The patient’s medical records are lost. What do we do now?
So, this is something that happens very rarely but it can happen. So sometimes the medical record is lost momentarily. So, from one visit to another, the file is lost but it is found after two or more visits later. Then, sometimes the file is lost forever. So that can also happen. So, it is important to know that the loss of the file is something that is a major deviation from good clinical practice. The medical record should not be lost. It is an extremely important element for the study because it is from this medical record that we will retrieve the data that will be used to analyze this clinical research. Therefore, this record is proof that the patient exists, proof of everything that has happened to the patient. So we need this medical record and losing it is very problematic. Well, that’s something that happens. So what do we do about it? First, we’re going to have to ask the clinical study technicians and the investigator to look for the medical record. They have to do everything possible, everything possible to be able to search for that medical record, to try to find it. If after a while, and after multiple searches, they don’t find the file, we have to try to see if there are any reports that would be computerized. So sometimes in some hospitals, medical records are computerized. So it is a little less problematic because a good part of the record is computerized. However, in other hospitals, the record is still in paper form. If the paper file is lost, sometimes it has been typed into a computer and there is still the report that is still in the secretary’s computer and you can use that report, reprint it and have the investigator sign it again to get the paper version. You can do that so that you can try to reconstruct a medical record for the patient. For your part, you have to document the situation in your report. You usually have the study deviation tracking charts, so of course you have to fill out that chart, and then send a follow-up letter to the investigator. So, if for example at a visit, you don’t have the file, send the letter explaining that you haven’t found the file yet, could you look for it, etc…. Really explain the facts in the follow-up letter until the most positive solution can be found for that case. There you go, so I hope this video will have helped you in the monitoring, to improve your monitoring.
I would also like to tell you that Pharmaspecific has created a white paper for
explain to you “how to conduct your clinical studies successfully”. This is a 100-page guide. It is feedback from our team to help you better understand clinical trials. You can download this guide below of the video. If you want more clinical research tips, you can go to the clinical research blog site. You will find the link here. You can also go to the Pharmaspecific website. You will find the link here. Pharmaspecific is a CRO specialized in clinical research. If you would like to have more information about the types of services we offer, you can go to our site.
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