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