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This is the first monitoring visit what is your priority?

Hello everyone, this is Vanessa Montanari from the clinical research blog.

So, today, I wanted to answer a little game that I had launched on linkedin, facebook and instagram.

In this game, I asked you, let’s play a little. It’s your first monitoring visit, oops, the investigator explains that he will only be able to see you for an hour after all. What will be your priority?

• Answer A: Possible SAE
• Answer B: Criteria for inclusion and non-inclusion
• Answer C: SDV
• Answer D: Informed consent.

Put your answers below. Nothing to win, just a game between professionals. In fact, I wanted to see a little bit of the answers that were going to be given by professionals in clinical research on this topic. There were 33 I like and 43 comments. So, comments from people from several countries, clinical research professionals from several countries.

Now, what I’m going to do is I’m going to review with you the answer I’m proposing for this question and then you can also give your opinion in the comments in the post.

So, in fact, first of all, indeed, there are some who have noticed that

I had noticed that the doctor gave us an hour. So, yes, the fact that they gave us an hour was a small element that I had inserted in the text to create a diversion and it was a small trap because in general, being able to have an hour with the investigator is a chance but the problem is mainly how much time we have to work alone, more than how much time we have with the investigator.

Then, what I wanted to tell you is that in fact, good clinical practices have been put in place in order to conduct clinical studies that are ethical and that respect the rights and safety of the patient. So that’s why you have to start by checking consents and SAE.

Why consents first? Consent because before you can open a patient’s medical record, the patient must agree. When you open that medical record, he or she must agree to participate in the study. Therefore, you cannot begin to study serious adverse events until you have signed informed consent. You must first check that the consent was signed before any study procedures, that the patient and the investigator signed on the correct dates and that a copy was given to the patients, but also that the investigator specified how the consent process took place. Then, the second most important thing to do is the audit of the CAS. So, it can be complicated to audit CAS in the sense that you may get to that first visit and there are several patients that have been included. If you have an oncology chart, for example, which is very thick sometimes, there may be four or five charts for the same patient, it’s going to be difficult to go through it all at once, get the SAE and not miss anything. So, what I recommend when you want to check for SAE, whether it’s the first monitoring visit or at other monitoring visits, the first thing you have to do is ask the clinical study technicians if he’s with you or the investigator if among the patients, has there been a concern, has there been a hospitalization, has there been a significant event that would have affected one of the patients in the study. So that will allow you to know whether or not there would be an SAE before you even have to look at the medical records. That way, it will allow you to refer you to a file. Then, the answers that followed, of course, were the inclusion and non-inclusion criteria before you start checking that the CRF is completed. We’re going to start by seeing if the patient entered the study correctly and that the inclusion and non-inclusion criteria were met by the investigator. So it also affects the safety of the patient, because the inclusion and non-inclusion criteria are there to allow patients to enter a study safely. So, if we don’t check this element in the first ones, it’s a bit embarrassing. Then lastly, of course, there is the SDV, whose source is data verification, so it’s the comparison between the CRF and the patient’s medical record.

In any case, thank you for playing with me on the different networks with this question. Then, if you liked this podcast, share it with people you know, people who would need it.