Patient Information and Informed Consent Before being admitted to the clinical study, the patient must consent to participate after the nature, scope, and possible consequences of the clinical study have been explained in a form understandable to her [Form 01]. An informed consent document, in Arabic language, contains all locally required elements and specifies who informed the patient [Form 02]. After reading the informed consent document, the patient must give consent in writing. The patient's consent must be confirmed at the time of consent by the personally dated signature of the patient and by the personally dated signature of the person conducting the informed consent discussions.