The Clinical Observational Study (COS), formerly the Clinical Validation Study (CVS), 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 language and 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 are shown separately in the Appendices. The model is based on the model which had been developed in the IMI Big Data for Better Outcomes (BD4BO) project.