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one of the most common mistakes that CRA s make during site selection visits is they do not obtain a copy of the sites standard operating procedure specifically for the informed consent process so you want to ask the site first of all you want to ask the site to verbally explain what their process of consent is for the study for theres study subjects then you want to ask them for a copy of their SOP for this process their standard operating procedure I see a lot of C raised during site selection visits forget to ask you this forget to ask to collect the SOP for the informed consent process and forget to ask the site to verbalize their process of consent now most sites process of consent is going to be something similar to this patient is seen in a private room with PI or other staff member plenty of time is made for questions for the study subjects to ask a copy of their informed consent is given to the subject after they sign it the patients are encouraged to take the informed conse