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Challenge # 3 The medical file is in electronic version, What should I pay attention to?

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Hello everyone !

 

This is Vanessa Montanari and from the clinical research blog for

Pharmaspecific. Today we will approach a new topic you realize that there is no paper medical record and that there is only an electronic file we will say computerized what is you must do?

 

So either having a computerized record is not a problem but it all depends on what type of computerized record you have. If the computerized file is just a file on a hard drive that is typed by the secretary and that there is no audit trail, so an audit trail is called « un tracé d’audit » in French. The audit trail is something that lets you know who wrote what as to what time who entered this document at what hour and that lets you know who did what when it’s something that is used by auditors to check what happened on a document and this audit trail in documents. For example if it’s a an electronic medical record is just in a computer which is written by a secretary and is not a real computerized file there will be no audit trail this is something that is verified by the clinical research associate from the selection visit. So we check if we are says that we have a computerized file, we check that this file have an audit trail and that the investigator can sign the medical report of theirs patient file. If the patient file is computerized but didn’t have an audit trail, the investigator need to print all the patient visit reports, signed and dated them. In fact the computerized dossier as it is not acceptable for clinical research. If on the other hand it is a computerized medical file in the hospital and that they have a particular software you must ensure that the doctor can date and sign the report and that there is a audit trail to check what happened on this file. For example if the document was deleted, so that we can be able to see that the document has been deleted if a sentence in a report has been modified we can know that we modified this sentence and who modified this sentence or must have an audit trail which you must check all that and then most importantly you shouldn’t use passwords from clinical study coordinators or the investigator to do your monitoring. You must have your own password to enter the patient’s medical record since in clinical research passwords, generally, it’s not just clinical research, passwords and IDs are personal. It’s not something you can share with the investigator, the clinical study technician or even with another company collaborator this is what you should be careful about when working with a computerized medical file.

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