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Challenge # 20: What to check when signing an informed consent form?

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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. What do you look for when you’re checking signing an informed consent for a first patient?

So, first of all, you need to make sure that the investigator who signed the consent is an investigator licensed to practice medicine. You can see this on the CNOM website. This physician, he must also be on the delegation log, the task delegation form. Secondly, you must make sure that they signed either on the same date or that the investigator signed after the patient but the reverse is not possible. I refer you to my video of challenge number 1 to see why, in detail, this is important. Thirdly, you have to make sure that all the fields have been completed, that the crosses have been put where they should be in this consent. Fourth, you must ensure that a copy has been given to the patient. This information must be in the medical record. So you have to make sure that a copy has been given to the patient. This information must be in the medical record. You must also make sure that the information and personal data is true: the patient’s first and last name, address and date of birth. You must make sure that the patient has signed his or her consent  prior to any study procedure. For example, some investigators may be aware that the patient must be tested for hepatitis B as part of the study. Then, even before the patient signs the consent, the investigator will have the patient tested for no reason other than the reason for the study. You must make it clear to the investigator that this kind of thing should be avoided and that the patient can only start testing once he or she has signed the informed consent. You must also make sure that the investigator of the study has reported to FDA 1572, if it is an IND study. IND studies are studies that are intended to be marketed in the United States and this form is required for this type of study. Therefore, you must make sure that the investigator has reported on this form. You must also make sure that the consent process has been done correctly. In principle, the investigator must indicate the consent process in the medical file. For example, the consent was reviewed with the patient, the consent was signed on a certain date, the patient had time to ask all the questions necessary for the study. That’s what I wanted to tell you about informed consent.

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