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Challenge #28:What are the essential tools for quality monitoring?

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Good morning, everyone. This is Vanessa Montanari from the clinical research blog for Pharmaspecific.  Today, I’m going to talk about the essential tools for quality monitoring. So what are the tools you need to do good monitoring.

First of all, you need a tool to calculate time intervals. That is, patient visits should be made at specific intervals or intervals of plus or minus seven days. These are the intervals that must be respected. And you if the interval is not respected, you have to report it as a deviation. It will probably be a minor deviation, but it will be one. Minor if it’s a short one day, for example, but it depends on the exam. Really, you have to refer to your protocol. So, as you have this naval, you have to use tools for that. So what I recommend is that you use tools on your cell phone. That way you can carry that tool around easily and you can find the information easily. You have for example the tool that is there. So I have an iPhone. So this tool, try to see if you can find it in equivalent if you do not have an apple phone. So, this tool will also allow you to calculate the next doses your patient should take, the delayed doses. It’s a tool I find essential because it’s complicated to take a small calendar and look, to check day by day how long before the next visit is going to be. Now it calculates automatically, it’s much simpler. The second very useful tool is a medical dictionary and a drug dictionary. At one time I used Dosrosz a lot. Now I use a mobile application instead.

So, you’ll find there. It’s an application that’s on the iPhone again. I think there are equivalents. So there’s this application, again, it’s a medical dictionary that I’m actually using that’s online and I think it’s very good. So if I ask myself a question about what a term means, for example, of course you have the choice of asking the clinical study technicians or the doctors, but before doing so you can search the internet or look in your medical dictionary. Then, ultra useful, it is your protocol in pocket version. So, we don’t have it on every study but when it’s possible, it’s really just great actually. It’s a small version of the protocol that you can look at, you put post-its on it, you can put your notes on it and find the information at any time. It’s much more convenient than having it on the computer because on the computer, you have to open it, look for the page, there’s 80 pages, it’s complicated. But I like the protocol in paper version, in a small version. It’s not very good in oncology, but I always have a paper version. Well, when the protocol is not very thick you can avoid it, but when it is thick enough, it’s good to have the smaller version. So, it’s a small version that is not very big. It’s that big and you can easily slip it into your bag and it makes your monitoring bag a little less heavy. If you are not offered this tool in your company, you can do it yourself and cut it out with a cutter and you put rings, a spiral to make it fit. That way, you will have your mini protocol. If you have the time to do it, it will allow you to see it in any case in a small format.  Another interesting tool, so there, you can just have it on your computer.

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It’s the CRF filling guide because sometimes the centre will ask you questions. Normally, they are supposed to have read the filling guide. So do you, but sometimes you actually forget some things. So it’s good to have it so you can go over the little things you might have forgotten. You also have to have what’s called the CTC-AE. In fact, it’s a guide with all the adverse events. So it’s been done for oncology, but it can be used for many pathologies to give a grade to this adverse event. So it’s useful to have that tool. You have it in application on iPhone. You must have the list of tasks that you will perform on site. Example if you need to check the criteria for inclusion and non-inclusion of the patient. For which patient you have to check that, the consents for which patient you have to check them. If you need to check… if for example you didn’t have time to check the adverse events, all the adverse events last time, from when you need to check the events. A tool that is useful because it will help you at least, to write your report, it will help you on the day of the visit. You will be able to look at it on a regular basis. Your to-do list, you look at it on a regular basis, it’s going to help you because you’re going to write down the documents that you have to retrieve, the documents that you have to get signed and you’re going to check them off as you go along. So you’re going to make your report. You know, you have to do this, this, this, this… In fact, it’s all written down there. What do you have to do? Did you do it.

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You can simply report this in your report from your tool. So, post-its. It’s useful but it depends on the tastes of the companies that refuse the use of post-its by staff members because post-its can be a source of errors since they have to be used correctly. They should not be used to clearly note things that are wrong. In fact, they are mainly used as a one-page indicator of what you want to show the investigator or the clinical study technician, but that’s not what you’re going to write down, it can’t be the only place where you write down the things to do, the things you want to see with the investigator. You also have to have your own document, a sheet of paper where you’re going to write down what it has to do with the investigator. To see what the others have to do, with the investigator, with the clinical study technicians, I have what I call monitoring and titine notes. In my former life as an employee, I had worked in a CRO in which this type of tool was used and I kept this process. It’s actually a tool that I created where I note all the problems with the centre, all the concerns and all the corrections that I request from the centre. Each time the correction is made, I note that it is made and this tool is also used to write the report. Since this way I can I can know what corrections I have asked for, from whom and has it been solved. You must also have your patient worksheet. In fact, this is your work tool to do your monitoring. So, you have probably prepared a tool that allows you to make sure when you do the VDS, so source data verification, that the VDS is done correctly, that all the information has been verified. So it’s your tool, it’s up to you to prepare it, one person’s tool is not another person’s tool. So, sometimes, on some studies, the project managers take the initiative to prepare a patient worksheet to help you.

But it is still up to you to prepare your worksheet because it will be personal and everyone works in a different way. What is also important is to have a worksheet form at your disposal with you for monitoring.

By the way, this is a worksheet, what is called an AE worksheet. In fact it is a worksheet that you will provide to the center. So, if, depending on the way their medical record is made, you may have to provide them with this document, to help them to better retrieve the adverse events. You will do the same for concomitant treatments. So it’s good to have these types of documents with you, print them out so you can provide them quickly. That way, the centre makes photocopies and then uses it if necessary. You can also have excel or project-specific tables, project-specific calculations. That’s it, project-specific tables. I’ve had some in oncology, for example, to help you with calculations of targets in oncology even though the investigator is responsible for doing calculations for example for resistance. But it is also your role to check that all this is done properly. So, you can have your own calculation tables, your own verification tables. You can create by yourself where to find them on the internet. Another very important document is your checklist of the investigator’s ranking, since it is the checklist that will allow you to check that the workbook is complete.

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It is a checklist that you created initially or that was initially provided to you by the project manager and then little by little this checklist will be updated with the new documents that will arrive. For example, if there are new amendments, the checklist will evolve. I recommend that you make a computer version of the checklist. In the computer version, you check off what is present and what is not present in the workbook. Then, this checklist will evolve and you will integrate additional lines in this checklist and it will always be up to date and it will also have … you will have in this checklist in fact all the documents that are currently present on the site. Also think about having the SUSARS list because you have SUSARS to check. It’s true that throughout the videos I’ve been doing for the last few days I haven’t talked too much about SUSARS but it’s something that needs to be checked on a regular basis and so you need to have the list of SUSARS that are provided to you by your project manager and follow that list. So you check off as the SUSARS come in and you have the SUSARS. You check them as you go along.

I hope this video has helped you, if you want to know more about clinical research, to go to the clinical research blog, the link is here. If you want to know more about Pharmaspecific, you can go to the Pharmaspecific website, the link is here. So Pharmaspecific is a CRO specialized in clinical research. If you liked this video please put I like at the bottom of the video and give me some comments, it will be my pleasure. I could answer you as well. We can exchange. You should know that Pharmaspecific has created a white paper to help you better understand clinical studies as an arc or as a project manager. So if you are interested, you can download this guide at the bottom of the video. It’s a feedback from our team of about a hundred pages. So I’ll let you download it if you’re interested. Thank you very much for following us and see you soon.


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