An Investigator’s Brochure (IB) is a compilation of data on the investigational medicinal product (IMP) (the medicine being studied) which is relevant to the study of this product in humans. It includes clinical and non-clinical data, i.e. any data from studies with patients (clinical) and data from other sources such as laboratory tests (non-clinical).
The purpose of the IB is to provide the investigator and others (e.g. clinical trial coordinators, study nurses) with background information to help them work in line with the protocol.
The IB is prepared by the sponsor. They also control the distribution of the document. This is because it is the single most comprehensive document summarising the properties of the IMP.
It provides the clinician or potential investigator with information they need to assess the appropriateness of the trial, including the benefit-risk relationship. It allows them to do this in an independent and unbiased way.
It provides insight to support the clinical management of study participants during the clinical trial. This includes information about doses, dose frequency, methods of administration and safety monitoring procedures.