Regulatory & Documentation
Informed Consent Form (ICF)
An informed consent form (ICF) is the document a clinical trial participant signs after a documented informed-consent discussion confirming they understand the study's purpose, procedures, risks, benefits, alternatives, and their rights as a research participant.
ICFs are governed by FDA 21 CFR 50, ICH E6(R3), and the Declaration of Helsinki. The signed ICF must precede any trial-specific procedure and is a foundational source-document; missing or improperly executed ICFs are among the most common FDA inspection findings (Form 483s).
Modern ICF best practice emphasizes plain-language drafting (8th-grade reading level), layered consent (key information first, details on demand), and translation quality control across multi-country trials. AI-assisted ICF authoring ensures consistency with the protocol's risk profile and produces site- and country-specific variants from a single source.
Related terms
Clinical Trial Protocol
A clinical trial protocol is the master document that defines a clinical study's objectives, design, methodology, statistical considerations, and operational conduct, and that all investigators must follow to ensure scientific validity and participant safety.
Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is the international ethical and scientific quality standard, codified in ICH E6, for designing, conducting, recording, and reporting clinical trials that involve human participants.
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