Contains Nonbinding Recommendations
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Reports.)
7. INVESTIGATOR'S BROCHURE
7.l Introduction
The Investigator's Brochure (IB) is a compilation of the clinical and nonclinical data on
the investigational product(s) that are relevant to the study of the product(s) in human
subjects. Its purpose is to provide the investigators and others involved in the trial with the
information to facilitate their understanding of the rationale for, and their compliance with,
many key features of the protocol, such as the dose, dose frequency/interval, methods of
administration: and safety monitoring procedures. The IB also provides insight to support the
clinical management of the study subjects during the course of the clinical trial. The
information should be presented in a concise, simple, objective, balanced, and non-
promotional form that enables a clinician, or potential investigator, to understand it and make
his/her own unbiased risk-benefit assessment of the appropriateness of the proposed trial. For
this reason, a medically qualified person should generally participate in the editing of an IB,
but the contents of the IB should be approved by the disciplines that generated the described
data.
This guidance delineates the minimum information that should be included in an IB and
provides suggestions for its layout. It is expected that the type and extent of information
available will vary with the stage of development of the investigational product. If the
investigational product is marketed and its pharmacology is widely understood by medical
practitioners, an extensive IB may not be necessary. Where permitted by regulatory authorities,
a basic product information brochure, package leaflet, or labelling may be an appropriate
alternative, provided that it includes current, comprehensive, and detailed information on all
aspects of the investigational product that might be of importance to the investigator. If a
marketed product is being studied for a new use (i.e., a new indication), an IB specific to
that new use should be prepared. The IB should be reviewed at least annually and revised as
necessary in compliance with a sponsor's written procedures. More frequent revision may
be appropriate depending on the stage of development and the generation of relevant new
information. However, in accordance with GCP, relevant new information may be so important
that it should be communicated to the investigators, and possibly to the Institutional Review
Boards (IRBs)/Independent Ethics Committees (IECs) and/or regulatory authorities before it is
included in a revised IB.
Generally, the sponsor is responsible for ensuring that an up-to-date IB is made available to
the investigator(s) and the investigators are responsible for providing the up-to-date IB to the
responsible IRBs/IECs. In the case of an investigator sponsored trial, the sponsor-
investigator should determine whether a brochure is available from the commercial
manufacturer. If the investigational product is provided by the sponsor-investigator, then he or
she should provide the necessary information to the trial personnel. In cases where preparation
of a formal IB is impractical, the sponsor-investigator should provide, as a substitute, an
expanded background information section in the trial protocol that contains the minimum
current information described in this guidance.
7.2 General Considerations
The IB should include: