Informed consent form (ICF)
In Documents & records
Also known as: patient information sheet, PIS
The informed consent form is the written document a participant reads and signs to record their agreement to take part. It explains in plain language what the trial involves, its risks and possible benefits, alternatives, how data will be used, and the right to withdraw at any time. It must be approved by the ethics committee before use, and updated when important new information appears.
Why it matters
Consent problems are among the most common findings in inspections. Version control, dating, and signature order are checked closely.
Example
When an interim safety review adds a newly identified risk, the ICF is updated, re-approved by the ethics committee, and participants already in the trial are re-consented on the new version.
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