" /> Informed Consent Process - CISMeF





Preferred Label : Informed Consent Process;

NCIt related terms : Informed Consent Procedure; Description of Informed Consent Process;

Alternative definition : CDISC: The procedure by which informed consent is obtained and documented by means of a written, signed, and dated informed consent form. This process may include obtaining assent from subjects with legally authorized representatives. (ICH GCP); ICH: The procedure by which informed consent is obtained and documented by means of a written, signed, and dated informed consent form. This process may include obtaining assent from participants with legally authorised representatives.;

Codes from synonyms : ICH M11-Section 11;

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24/07/2025


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