Challenge # 14 Monitoring visit: The investigator site file, What to check?

Partager l'article :
     
  

Challenge # 14 Monitoring visit: The investigator site file, What to check?

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.

Good morning, everyone. This is Vanessa Montanari from the clinical research blog for Pharmaspecific. Today we’re going to look at a new topic. We’re going to talk about managing the investigator binder. How do you manage the Investigator’s Workbook? What to check?

Text transcirption :

So, the investigator binder, as you know, every investigator has an investigator binder. This binder is a binder containing what we call essential documents. Essential documents are the documents that are found at the level of good clinical practice. These documents should be in the binder or at the sponsor’s site. As a Clinical Investigator, you are responsible for checking with both the sponsor and the investigator that these documents are in the right place. However, it is the responsibility of the investigator to ensure that the binder is up to date. That is, the investigator is responsible for putting a number of documents in this binder with your help. Often, clinical research associates do this and investigators are only minimally involved in this task. Clinical study technicians do not do this as well. However, it is their responsibility. Therefore, it is important that clinical study technicians are aware of the contents of their binders because in the event of an audit, the investigator will be responsible if documents are missing from the binder. As a clinical research associate, in order to be able to update this binder, it is preferable to create a list, a checklist of the investigator binder. This checklist is useful. It will be used in case of a change of clinical research associate. The clinical research associate will pass on this checklist to the next clinical research associate, the clinical research associate can also use the checklist from one visit to the next to ensure that the Investigator’s binder is up to date. From one visit to the next, the CRA will insert additional lines in the checklist to ensure that the CRA will use this list from one visit to the next to ensure that the binder is up to date. It is also important to specify in the visit report that such essential documents are missing from the binder and will need to be brought back at the next visit. The clinical research associate may also send the documents with the follow-up letter that he or she sends to the investigator after each monitoring visit. However, it is always preferable to bring the documents back yourself to avoid that the documents are not put away, that they are left by the investigator with the binder without necessarily being put away.

I hope this video has helped you to improve your monitoring. If you liked this program, please put I like at the bottom of the video. The Clinical Research Blog is a blog where you can get a lot of information about clinical research, so don’t hesitate to visit it. The address is here. If you want to know more about Pharmaspecific, our CRO specialized in clinical research, you can learn more by going to this address. I also wanted to tell you that Pharmaspecific has written a guide to help you better understand clinical trials as a CRO or as a project manager. So I encourage you to download this guide. It’s at the bottom of the video there. Thank you for following us and see you soon. Bye!

Recherches utilisés pour trouver cet article :https://blogdelarechercheclinique com/le-classeur-investigateur-que-verifier/,https://blogdelarechercheclinique com/le-classeur-investigateur-que-verifier/#:~:text=Donc, le classeur investigateur, comme niveau des bonnes pratiques cliniques,checlist classeur investigateur,classeur recherche clinique,https://blogdelarechercheclinique com/le-classeur-investigateur-que-verifier/#:~:text=Cependant, la responsabilité de s classeur et avec votre aide,le classeur investigateur,Check-list de vérification du dossier investigateur,Classeur investigateur definition,gestion classeur investigateur,le classeur investigateur recherche clinique
0 0 votes
Évaluation de l'article
S’abonner
Notification pour
guest

0 Commentaires
Commentaires en ligne
Afficher tous les commentaires