Skip to main content

Challenge # 1 – Do the investigator and the patient have to sign the consent on the same day?

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.

Text transcription :

Hello everyone!

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

Today, I’m going to return to a subject I had discussed on linkedin that had caused a lively emulation on this network with different answers. The question was: do the investigator and the patient have to sign the consent on the same date?

So I will use the ICH GCP R2 (good clinical practice) text to answer this question. In particular, part 4.8.7. In this part, it is stated that the patient must be informed about the study, must have asked all the necessary questions to the investigator before signing the informed consent. This means that the investigator must ensure that the patient has understood the study and that all questions are asked before signing. Therefore, it means that he cannot sign before the patient because he must make sure all of this is done before signing. If they sign before the patient, it means that the patient has not made sure of these aspects.

Les personnes qui ont lu cet article ont lu aussi  Ecoutez l'interview de Vincent DIEBLOT, directeur du F-CRIN

The second question we can ask ourselves is, do they both have to sign at the same time? The answer is usually yes, they both have to sign at the same time, because even if the patient takes the consent form, they have to take it home to read it with their family. The patient is not supposed to sign the consent until there is a final discussion with the investigator. Normally, the patient comes back to the investigator with the consent, they discuss it again, the investigator checks that the patient has understood and asked all the questions, and they both sign. They are face to face or next to each other. They both sign the consent. So in principle, they cannot sign on different dates. However, I would like to make one small point. I had a special case. An international study in which patients came from different countries and they came to France for treatment. The way the study worked meant that he could not be with the investigator to sign the consent. In the end, they could not be face to face with the investigator to sign the consent. Even though they had retrieved the informed consent to discuss it with the family, they could not see each other, see the investigator. In this case, it was something that was specified in the protocol. How the study would work, how the consent process would work, was specified in the protocol and it was submitted to the ethics committee. And the ethics committee validated the process of obtaining informed consent. So we can have rare cases where the patient will sign before the investigator. But on the other hand, we can’t see the opposite. And if we have this rare case, the protocol would have to specify it and it would have to be validated by an ethics committee.

Les personnes qui ont lu cet article ont lu aussi  5 questions pièges posées pendant un entretien d'ARC

That is my answer to that question. I hope it 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 liked this program thank you to put I like below the

video. If you want to know more about clinical research, you can go to the clinical research blog. The link is here. If you want to know more about Pharmaspecific, you can go to the Pharmaspecific website by going to the link here. Thank you very much.

See you soon! Bye!

Si tu as aimé cet article, je te remercie de « liker » ou de partager avec tes collègues et amis Attaché de Recherche Clinique :)

Laisser un commentaire