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Challenge # 29: Tips from an experienced ARC !!!

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Good morning, everyone. This is Vanessa Montanari of the clinical research blog for Pharmaspecific. Today, I’m going to give you old CRA tubes for better practice monitoring and monitoring of premium quality. Little tip, read again the monitoring guide on a regular basis. The monitoring guide is in fact a guide which was written by the project leader of the study, which explains the different monitoring activities that you must to do, the things you need to check. Sometimes studies are not necessarily to be monitored 100%. It is only certain data that must be monitored.

So in order to be able already doing good monitoring, follow your monitoring guide. It is the leader project took the time to you prepare this document. It is necessary to use it and review it in such a way regular to get back on track some things because sometimes we forget it. Usually the monitoring guide talks about both the implementation visit and the place until the closing visit. So you have a whole range of things to check throughout this period and the guide usually talks about all those parts there. In any case, be very careful about this guide because it is really important. Well, another tip, when you visit monitoring, remember to reserve some working sessions with the various stakeholders. You make an appointment with the investigator, the study technician with the pharmacist and then the other stakeholders, if there are others on your study. Set a good schedule for each of the stakeholders and try to get a range that’s close enough between each speaker for have time to work with everyone of them. Be sure to ask for a meeting with the investigator. That is to say … just because you asked for a site visit that the investigator coming to you or even spontaneously. You must claim a schedule for them to spend to see you. In general, I would recommend to ask him to stop by instead an hour before you leave. That’s a… a little better, rather than early morning or late morning because you won’t get the time to collect all the questions that you have, and as a result there will be questions that will only be not deal with him if you do too soon. Afterwards, there are questions that you can ask site study coordinator all day long. Maybe he can answer some questions, pretty simple things, but all that which is medical, it will often be the investigator. Of which, you will often in the late afternoon with him. An hour and a half before it’s not badly like that, it also allows me to be able to make things right with the site study coordinator at the time corrections. Then, something else, do be careful with the use of post-its. The post-it, it can’t be the tool that’s going to get you to keep in mind the information. You must have your own notebook next to it or a document that allows you to keep the information, but the post-it on which you write, you leave post-its for corrections and if you leave with the post-its with the corrections, but I’ve seen cases where post-its had all been abducted by the center and so you find yourself without post-its without any information. The post-it is a help to be able to find the pages. Possibly put notes on it, but you have to always that you duplicate. If you use post-its, always duplicate on a notebook the post-it. That’s nice, but… you have to be very careful because that’s something that can go away, it’s something that comes off; and if someone peels off your post-it and you didn’t notice information elsewhere, you risk forgetting to make the correction regarding your visit from monitoring. When you make an appointment for your visit, i think it’s interesting to send with a letter of confirmation, when you send the confirmation mail to say that you will come this day to such and such a time, i think it might be interesting to attach the old follow-up letter that you sent from the last visit to remind the center that there were actions they had not been treated and to remind them that he he needs to review this letter before your coming and that he may be dealing with of the latest actions. In principle, between two visits, you follow the center but depending on your activity, you may not have time for everything to follow. So it’s good to send this letter back with your confirmation one week before coming. That way, you get the time to the site study coordinator and the investigator to be prepared, and possibly remember that there are had such a subject that it had to be dealt with and address the subject before your come. Also remember to bring back at the time of your visit to monitor documents that may be useful to you. You bring them in duplicate so you have a small copy in case you need it. So, when I talk about some documents, I am talking about a copy of delegation log blank. Just like that, if you don’t know, in the folder there is no more, well you’re out of it will have one to propose to the center. You can make photocopies. There you go, then you can also see it on a USB key or save it to your computer but you have to take the time to find the means of printing etc … That’s why a small version  already printed, it can be interesting. You can also do it for training forms, the training form, the training, since you may be going to is required to train a center or someone from the center may need to train someone and that form she’s not gonna get it not where she won’t get it anymore. You’ll get this form to be proposed to him immediately. He’ll be in your monitoring business. You can also do this for event fill tools and worksheets, which we’re not allowed to do calls worksheets, actually, it’s the work tools to help the recovery of adverse events or assist in the treatment recovery concomitant You can have this type of copy also in your business in version printed to be able to give it away quickly and then help your center as soon as possible when you visit monitoring. Me, what I recommend, you have prepared your monitoring visit, you’ve made a checklist of all the things you had to do during this visit. This checklist, it should be used on a regular basis throughout the visit. That is, when you come in, you’re going to look at your checklist. In this checklist, you are going to put the activities to do, you will put the documents to sign the documents to be recovered and throughout during the day, you’re going to follow this checklist but above all there are key points where I recommend that you review your checklist to see if some things haven’t been done. For example, after the meal you take your checklist and make a good balance sheet. Since this morning I’ve been doing this, this, this, this, this, this. I still have that to do. You check that you didn’t forget to check in something you had to do and you also do it at the end of the day because sometimes we had to pick up a document. The clinical study technician told us that he’s gonna go get him and then afterwards. You forget, he, forget and then you leave without documents and that’s it. So, then …, recheck at the end of the day before leave. So, this, this, this. Is that… it’s good, and this way, you’re sure that you’re leaving with everything you’ve got need, everything you had planned. Everything you planned to do, you’ve checked it if you can’t not doing it right. Do you know why you didn’t, but you’re watching your checklist well at the end of the day. So, in the morning, at noon and at the end of day, you really do do a complete check-up from your checklist to see where are you in. So, mostly don’t forget about codes for access to computerized medical records, especially do not use technician codes clinic that works with you. Be sure to ask for all of this when you come to the set up, at the time of selection. How does it work and especially always make sure you have your codes. It is forbidden to share your codes in clinical research. It is forbidden to share in general in the work. So, to avoid getting into situations where you can’t work properly. Compared to the communication with the investigator and the site study coordinator generally try to put regularly the investigator with a copy. So already when you make an appointment, with them, you always copy it. When you have a topic that deals with patients on the study, on the protocol copy the investigator. Be sure to put the investigator in copy. Of course, if it’s to ask for a document that is not very important, it’s not necessary. But in general, try to put the investigator in copy. Why would you do that? Because if you never put the investigator in copy and that everything all of a sudden you copy the investigator only when there are problems, the site study coordinator could take offence at the fact that you alert the investigator thatwhen the
re’s a problem. If he’s informed on a regular basis and not only when there are problems, that goes a little bit better. We’d spend not too much like the one who denounces to the clinical study technician in a situation. Here, let him know on a regular basis. Of all the in many ways, he’s the one with all the responsibility. So he’s the one who needs to know about it things in particular and the site study coordinator is also informed, but he really needs to be informed. Last small recommendation, do not hesitate not start writing your report on the train. I know that sometimes we’re a little tired, we don’t really want to do it, but… if you have enough time, try to do it because it’s what you makes it possible to be a little more serene at the back. Plus, you have all the ideas that will be fresh. So you might want to do a little assessment of what you have planned. That is, the problems and then the actions to be proposed to the investigator. So you can actually Well, with the spirit, you did see that happened. You have good memories, you can better write and remember actually start writing a draft from the train if you’re not too much tired. Trying to do this is really very useful and then you’ll see that it will avoid having omissions in your monitoring report. I hope this video helped you. If you would like to have more information on clinical research, you can visit the blog of clinical research. The link is here. If you liked that video, thank you for putting I love at the bottom of the video and feel free to put comments, it will be my pleasure to know what you thought of it. If you I forgot something of interest that could serve everyone, if you want to know more about Pharmaspecific, our CRO specialized in Clinical research. The link is here. I would also like to tell you that Pharmaspecific has created a 100-page guide that is feedback from our team on how to apprehend the trials clinics, how to better practice testing as a project manager or as a clinical as an ARC. So, if you’re interested, you can download it at the bottom of the video. Thank you for having us followed and see you soon.

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  • marine M dit :

    Si une recherche arrive à sa fin de validité (2 ans) sans avoir démarrée.
    Une declaration de fin de recherche est envoyée juste après la date de fin de validité, mais je pense qu’il n’est pas necessaire d’envoyer de « rapport » puisqu’il n’y a pas de resultats ou de données…
    Qu’en pensez vous ?

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