A document describing the details of a clinical study (aim, intervention under study, duration…) that the clinician gives a person who is invited to participate in the study. The information sheet has several purposes, including that of helping to ensure that the patient receives appropriate and complete information, in order to decide whether to take part in a study; it is also a “take home” reminder of the elements of the clinical investigation, providing contact information, in case additional questions or concerns arise.
