An Informed Consent Form (ICF) is used to document that the subject (or the subject’s legally acceptable representative) provides voluntary consent to participate in a clinical study by signing and dating the written informed consent form. It must contain 20 ICH-required elements (refer to ICH GCP section 4.8.10). The language used should be as non-technical as practical and should be understandable to the subject (or the subject’s legally acceptable representative). This document must be approved by an institutional review board (IRB) or an independent ethics committee (IEC) before it is used.