The Feasibility Study must be based on a standard model informed consent form. That model informed consent form should then be adapted by each participating centre according to its own customs (to which the IRB is used) and be made disease specific. The model is attached here. In order to make the text more readable, the informed consent to participate and the privacy statement following article 13 of the General Data Protection Regulation have been separated. The model is based on the model which had been developed in the IMI Big Data for Better Outcomes (BD4BO) project.
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