Challenge # 4 The concomitant treatments are missing in the source file, what to do?

This year will be a year of meeting, sharing, knowledge and development. Are you ready with us It will start with our 2020 challenge, one video per day for 30 days on monitoring.
For 30 days, we will give you high added value content for quality monitoring!

Join us on Instagram by clicking here: https://www.instagram.com/blogrechercheclinique/
Do you need clinical research? contact PHARMASPECIFIC by going to our site by clicking here: https://pharmaspecific.com/devis/
If you have any questions about the profession of clinical research associate or a career in clinical research, you can put it in the comments below. We will get back to you as soon as possible.

Hello everyone !

This is Vanessa Montanari from the clinical research blog for Pharmaspecific.

Today we’re going to be looking at a new case. You have a large number of concomitant treatments in the patient’s medical records. However, not all the details are in the medical records. I mean, when I talk about all the details, you don’t have the doses, you don’t have the dose per day, how many times it’s taken per day, the start date. There is a certain amount of information missing, which makes it difficult for you to monitor your case book and to do what we call the VDS-source data verification-so, the comparison between the medical record and the case book. What do you have to do in this case?

The answer is simple, you don’t have a hundred thousand solutions. The solution you have is to offer the doctors and his clinical studies technician a pre-made chart so that he can complete all the information. That is to say that the clinical studies technician will, in this list, complete all the concomitant treatments of the patient and collect from the doctor the start dates, the end dates, the doses, the number of times the treatments were taken, the reason for taking this treatment, for which adverse events and this document will be dated and signed by the principal investigator. With this document, you will be able to do your monitoring since this document will serve as a source document. So you will have both the information in the medical file and this source document, which will be a working tool for the TEC, the investigator and for you.

So, I hope this video has helped you.

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’s a 100-page guide. 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, you can go to the clinical research blog, the link is here. If you want more information about Pharmaspecific, you can go to the Pharmaspecific website, the link is here. Pharmaspecific is a CRO, specialized in clinical research. You can get information about our services. If you liked this video, please put I like at the bottom of the video. Thank you all for following us.

See you soon! Goodbye.