Regulatory & Documentation
Investigator Brochure (IB)
An Investigator's Brochure (IB) is the comprehensive document, updated at least annually, that summarizes all available clinical and non-clinical data on an investigational product, allowing investigators to assess the benefit-risk balance for trial participants.
Per ICH E6(R3), the IB must be provided to every investigator before site activation and re-issued whenever new significant safety or efficacy information emerges. The IB drives the safety language in the ICF, the risk-mitigation strategies in the protocol, and the reference safety information used for SUSAR assessment.
Maintaining an IB across multiple ongoing studies and expanding safety datasets is logistically intensive. AI-assisted IB authoring keeps non-clinical, clinical, and safety sections synchronized with the underlying source documents and flags downstream documents (protocols, ICFs, DSURs) that require updating after each IB revision.
Related terms
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.
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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