NCIt related terms : informed consent form; Informed Consent Document; IC Form;
NCIt definition : A document explaining all the relevant information to assist an individual in understanding
the expectations and risks in making a decision about a procedure. This document is
presented to and signed by the individual or guardian.;
Alternative definition : CDISC: A formal document used during the informed consent process explaining the potential
risks and benefits of participation in a study and the rights and responsibilities
of the parties involved, in a manner that is understandable to the subject or their
legally authorized representative.; CareLex: A document to capture consent by a patient to a surgical or medical procedure
or participation in a clinical study after achieving an understanding of the relevant
medical facts and the risks involved. [NCI]; CDISC-GLOSS: Document used during the informed consent process that is the basis for
explaining to potential subjects the risks and potential benefits of a study and the
rights and responsibilities of the parties involved. NOTE: The informed consent document
provides a summary of a clinical trial (including its purpose, the treatment procedures
and schedule, potential risks and benefits, alternatives to participation, etc.) and
explains an individual's rights as a subject. it is designed to begin the informed
consent process, which consists of conversations between the subject and the research
team. if the individual then decides to enter the trial, s/he gives her/his official
consent by signing the document. Informed consent is sometimes administered electronically,
i.e., eICF. See also informed consent.;
Currated CISMeF NLP mapping