Clinical Research: How format can change a CRF presentation for the better?

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Transcription : Hello everyone, this is Vanessa Montanari from the clinical research blog. Thank you for following us for so many years. It’s been almost 5 years that we’ve been doing articles and videos, also podcasts in clinical research.

So today, we are going to talk about the paper CRF, the electronic CRF, since someone asked me how can I present a paper CRF or an electronic CRF during an implementation?

So if you have a paper CRF. By the way, you have to be careful not to annoy the investigator too much. For that, the best is to try to present the paper CRF to him as quickly as possible, within approximately 1/4 hour. Because if he is the one who is going to fill it out, he will still have to fill it out correctly. You will thus initially present to him the various types of page; types of page compared to the various visits which there is in this CRF. You are going to introduce him to the important pages such as AE pages, concurrent treatment pages and SAE pages. So that he can see how to fill them in because if they are not filled in correctly, it will be quite embarrassing for you and you will have to ask him for corrections regularly. So, you will explain to him how to fill in those pages properly. What are the rules for filling in the CRF. So, there are some basic rules for filling in a CRF. They will be in the CRF filling guides. So, this is what you should use so that you can actually prepare this explanation for the investigator.

Then, you also tell him/her about the pages that are unusual. Often your investigator is already an investigator, not a new investigator. So, he is used to filling out CRFs and you will have to put your fingers on things that are not usual for filling out a CRF. For example, procedure pages, treatment pages. For example, these are pages that are not always present. So, you will have to tell him about those pages if you have them.

Then, if you have an electronic CRF, then it’s a little bit easier. In fact, if your electronic CRF is an CRF that is already widely used in clinical research, you won’t have a lot of work to do because you’re just going to ask, obviously well before the implementation, if the investigator is already trained in that electronic CRF if his SC is already trained in that electronic CRF and then you’re going to get his training certificates back. It has to be recent. It depends on your CRO or your pharma laboratory. So there is a time limit often 1-2 years. They have to be trained 1-2 years before they can use the CRF. Then it depends on the version of the CRF because versions change so they have to be trained on the latest version. In this case, you will just have to present during the implementation, if they have been trained, only which CRF is being used and how often it needs to be completed for example. But you won’t have to do much. But if they haven’t been trained, they will have to do the online training. So you’re either going to ask them to do it up front so that on the day of implementation they’re ready for inclusion. Then, often, the electronic CRFs are linked to randomization platforms. So in that case, you would have to explain to them how randomization is done in relation to the CRF. That is, what role the CRF has in relation to randomization, because sometimes the CRF as the platform for randomization is very connected.

So I hope this podcast has helped you and I wish you a good implementation tour and see you soon.

Feel free to share this podcast so that others can benefit from these tips.

Goodbye.

2 years of experience as CRA, how to quickly become a project manager

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2 years of experience as CRA, how to quickly become a project manager

Transcription  : Hello everyone, this is Vanessa Montanari from the Clinical Research blog. Today, I’m going to answer a new question.

“I am writing to you for your advice. I have been an CRA for a year and a half and CRA 2 recently. I would like to become a project manager being from Bordeaux. What training would you advise me? Have a nice weekend.”

So, first of all, what I would like to say in relation to this question is that there, you have two years of experience, it’s very short to be able to become a project manager. For the simple and good reason that being a project manager also means being credible and with two years of experience, you don’t generally have all the knowledge necessary to be credible with the other CRA you’re going to manage. So, that said, that doesn’t prevent you from training as a project manager. There are several, there are training courses that target the project manager part a little bit; in the universities there are Masters II on this and then there must also be a private training course that does it in the Paris region.

Having said that, I think that this is just a plus for the day when you become a project manager, but it’s not what will allow you to get the job you want. In fact, the strategy that I recommend is to work in small structures or work in the hospital where you can more easily get this type of position with the experience you have. And because also in small structures, you will be more easily given the chance to touch different types of tasks and probably also to touch project management. And then you’ll see afterwards to get into bigger structures with your experience as a project manager.

That’s it, I think it’s the best solution to be able to evolve towards this type of position quickly if you wish. Otherwise, on average, to become a project manager in large CROs, it takes a minimum of ten years to reach the position of project manager. In the meantime, you can move on to the position of coordinator, which is called clinical trial manager. It’s a position that is just below the project manager position, and it’s more like managing the clinical research associate monitoring.

So I hope this message helped you.

Remember to register on the clinical research blog to get our book. We give you a lot of information there, it’s a mine of information that we’ve created for you. Don’t hesitate to go there and in particular to get the guides “how to train and find a job at CRA” and also “conducting a successful clinical study”.

Here you go, have a nice day and see you soon!

VLOG Forum Biotechno Paris 2020

VLOG Forum Biotechno Paris 2020

VLOG Forum Biotechno Paris 2020

Hello ! I hope you are well. So, this morning I’m going to the bio-techno forum fair. It’s a fair for young doctors. I’m going as part of my working group at AFCRO on clinical research careers. Today, we are going to discuss with young doctors to introduce them to the clinical research professions, to help them decide on the different professions that there can be. Of course, there are different professions even in the private sector. So, they will also be able to discover the other private sector professions, but we are here for the clinical research professions. There will be several industrialists who are sponsors of the event and who have come. That’s it, it’s going to be interesting. We will be able to exchange ideas. I’ll show you how it works later on. So, see you later … !

This is the first monitoring visit what is your priority?

If you need a CRA in France? Please contact www.pharmaspecific.com

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.