Definition

A document containing clinical and nonclinical information about an investigational product that is relevant to the study of the product in humans.

Example

The IB Section 7 lists known adverse reactions from previous studies. During a clinical trial, this serves as the RSI for determining if an event is expected or unexpected (SUSAR determination).

Regulatory source

ICH E6 (GCP), 21 CFR 312.23

Common mistakes

Not updating the IB promptly when significant new safety information emerges from ongoing trials.

Inspector question

How often do you update your IB? How do you ensure investigators receive current versions?

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