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According to the section on Informed Consent of Trial Subjects in ICH GCP the language used in the oral and written information about the trial , including the written informed consent, should be as XXXXX as practical.
What is the XXXXX?
According to the section on Informed Consent in ICH GCP, prior to a subjects participation in a trial the written informed consent form should be XXXX by the subject or the subjects legally acceptable representative.
What is the XXXX?
According to the Informed Consent Section of ICH GCP, when a clinical trial includes subjects who can only be enrolled in the trial with the consent of the subjects legally acceptable reprsentative, what is stated about the involvement of the subject in the informed consent process.
Which of the following is not listed as one of the subjects that written informed consent should include explanations of?
According to ICH GCP the informed consent discussion and written informed consent form should include what information about what is available to the subject in the event of a trial-related injury?
