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

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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 site file. 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 site file. 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!