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You go to the site and there’s no more consent. You went there last time, but they were there. And now there’s no consent. What do I do? What do I do?
Hi, everyone, this is Vanessa Montanari from the clinical research blog. I’m going to talk to you about a little case study in clinical research. So, the question is what to do if you went on site, the consents were supposed to be on site and now they’re not. What are you supposed to do? First of all, you have to talk directly to your investigator to see where these consents were put and if he knows where they are. Then, secondly, you contact your project manager to inform me of this problem and above all, you do not open the medical files. No consents, no medical records. Even if the consent was there before, you must not touch them. You must also document all this in the monitoring report and ask the investigator to document the information in the medical file. All consents must be signed again by the patient on the date the consent is signed. In other words, we do not backdate the consents. On the other hand, a small note can be put on the consent itself or the patient will write on the consent that he or she signed the consent “the time”, and the investigator can also put a small note that the consent was signed and that it is lost. This can also be used to show that things had been done by asking the patient to write this information on the consent.
That’s it. So, I hope that this little case study has helped you and that you are not in this situation. Good luck!
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