challenge # 9 I am replacing a CRA permanently, What to check?
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Text transcription :
Hello everyone! This is Vanessa Montanari from the clinical research blog for Pharmaspecific. Today we’re going to talk about a new topic: you are an ARC in a company and you’ve been asked to work on the new study because one of the other company employees is leaving. What can you do? That is, what to check? How do you prepare for this study? First of all, you have to ask the outgoing ARC for all the latest monitoring reports and follow-up letters. You should read them before this ARC leaves the study to see if you have any questions, so that you can ask the previous ARC all the necessary questions. Then you must make sure that a handover meeting is held between you and this CRA so that all the information is passed on to you and all the documents are given to you. In particular, it may happen that some CRAs, for some reason, take some documents from the centre and bring them back with them. So, you have to make sure that he or she has given you all the documents. In the event that they bring something back and the centre does not know about it, you should know about it so that you can retrieve all the necessary documents. You should also ask him for the checklist from the Investigator’s binder.
As a Clinical Investigator, you should normally prepare an Investigator’s Workbook Checklist summarizing what was in the Investigator’s Workbook at the time of the last visit. Therefore, the outgoing Clinical Investigator should provide you with this checklist. Beware, it is often the case that some people do not have this checklist. So, you need to know where you are in the Investigator’s binder. What documents are missing or what documents are currently present. Request this checklist! Then you must ask all the necessary questions to this clinical investigator before he or she leaves, because after he or she leaves, you will have great difficulty getting answers and you will have to work alone. What I also advise you to do is that at the time of the first monitoring visit that you are going to make to this center, your first time at the center, I recommend that you review all the patients’ consents to make sure that they are all present and also to check that they do not have any problem with the consents. For example, a consent that was improperly signed and not reported by the previous CRA. These are things that happen, and as soon as the previous CRA is gone, you become responsible for everything that happens. You have to make sure that the consents are there and that they have been signed. It’s going to take very little time. Depending on the number of consents, it may take you maybe 15 minutes, but I think that’s a minimum when you start at a centre to make sure that all the consents are present and that they’re properly signed, properly signed, because from one monitoring to the next, the previous CRA may have gaps in knowledge. On the consent you cannot afford to have this type of gap.
I hope this video has helped you to improve your monitoring skills. I would also like to tell you that Pharmaspecific has created a white paper to explain to you “how to conduct your clinical studies successfully”. It is a guide of about 100 pages. It is feedback from our team to help you better understand clinical trials. You can download this guide at the bottom of the video. If you want more information about clinical research, go to the clinical research blog. The link is here. If you want more information about Pharmaspecific, Pharmaspecific is a CRO specialized in clinical research, you can go to the Pharmaspecific website which is here. Thank you to put I like at the bottom of the video if you liked it.
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