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Investigator's Brochure Translation
During the drug development and approval process, good clinical practice and regulatory
compliance demand careful recording of clinical and non-clinical data in documents.
Investigator's Brochure (IB) are complex documents that provide investigators and ethics
committees with a broad overview of a product's development. All investigator brochures
will be prepared in accordance with Appendix I (Investigator Brochure Format and
Contents) which provides a model for the standard requirements. It is used by
investigators to ensure protocol compliance and is often submitted to regulatory bodies
as part of new drug applications.
The information provided here follows the relevant ICH guideline.
A disclaimer statement, such as 'This document contains information derived from
limited experience and may not be representative of proven safety and/or
effectiveness. The instructions contained herein should be followed to help minimize
toxicity or injury which may result from coming into contact with this medication or
Confidentiality statement. Each page must be marked confidential and all external
authorities who use the brochure must be instructed to treat the document
Table of contents which include a list of items addressed in the investigator brochure,
with page numbers.
A brief summary describing the pharmaceutical, physical, chemical, toxicological,
metabolic, clinical and other information concerning the stage of clinical development
of the investigational medication.
A brief introduction containing the drug's chemical name (and generic and proprietary
name when approved), all active ingredients, the pharmacological class, the rationale
for performing research, indications (the anticipated prophylactic, therapeutic, or
diagnostic indication) and the approach for evaluating the drug.