informed consent
- Guideline or reference source
- ICHE6(r1) Guideline for good clinical practice
- Definition
- A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.
- Abbreviation for
- IC
- Used For
- consent form
- informed consent form
- Related Term
- vulnerable subject
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