ICH E6(R3) – A person who is independent of the trial who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the participant or the participant’s legally acceptable representative cannot read, and who reads the informed consent form and any other documented information supplied or read to the participant and/or their legally acceptable representative.
CDISC-Gloss – A person who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject. [ICH]