Investigator’s brochure - summary of product characteristics - EC Research

An Investigator's Brochure (IB) is a summary of clinical and pre-clinical data on investigational drugs the pharmacological aspects of which are not yet or not sufficiently known and which are important for studying the investigational drug in subjects.

For registered products of which the pharmacological aspects are known, an extensive Investigator’s Brochure is not always necessary. Submitting the summary of product characteristics (SmPC) may then be sufficient.

If it concerns a study with a medical device, an information brochure about the device needs to be submitted. This should specify whether the device already has a CE label or not.

Other relevant information relating to the safety in the context of the research (including DMC charter and composition DMC if applicable) also needs to be submitted here.

Last edit: 1 March 2023