Article written by the Pharmaspecific Society, a specialist in clinical research.
Hello! This is Vanessa Montanari from the clinical research blog.
Today, I’m making a video to give you the three (3) important things to check at the first monitoring visit.
There are three (3) things that are really important.
First of all, it’s the SAE (serious adverse events). Sometimes it can be difficult to check this immediately when you’re on site. But the best thing is to question your investigator as soon as you arrive. For example, ask him/her if there have been any hospitalizations or important events during the patient’s treatment. What you can also do is look without the medical record, but that can sometimes take a little time. Time to get to the part where the patient might have been hospitalized or had an event that could be reported as a « serious adverse event. »
Next, you have a very important element: consents. You will check the consent of all patients before you open the patient medical file. If the patient has not signed a consent, you are not allowed to look at the patient’s medical record.
Finally, the third thing, which is also very important, are the inclusion and exclusion criteria. You’re going to look at whether the patient has the criteria to participate in the study or whether he or she should not have been included in this study. That’s also a third thing to look at.
So, when you go into monitoring, the three (3) things to check in order are:
– Consents
– CASs
– Inclusion criteria
I hope this little video helped you.
See you soon! Goodbye! Bye!
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