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.
Elements Contained in Successful Investigator's Brochures
The information provided here follows the relevant ICH guideline.
- Title page.
- 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 from overdose'.
- Confidentiality statement. Each page must be marked confidential and all external authorities who use the brochure must be instructed to treat the document confidentially.
- 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.
- A description should be provided of the investigational substance, including specifications and/or the chemical and/or structural formula(e). A description of the drug's physical, pharmaceutical and chemical properties, and how it was formulated is also needed.
- A non-clinical studies section that discusses the methodology and results of relevant toxicology, metabolism, reproductive, pharmacokinetic and pharmacology studies of the drug in vivo and in vitro.
- A clinical studies section that discusses and reports the effects of the drug on humans, focusing on pharmacokinetics, safety, efficacy. If no clinical data are available, a summary must be provided to explain why the data presented support the decision to use the medication.
- Marketing Experience. The investigator brochure should identify countries where the investigational medication/device has been marketed or approved. Any significant information arising from the marketed use should be summarized (e.g. specifications, formulations, dosages, routes of administration and adverse reactions).
- Medication Management. This section should provide the investigator with information on accountability and general handling of the study medication. Advice for management of accidental exposure or overdose must also be provided.
- A Summary of Data and Guidance for the Investigator. The purpose is to provide the investigator with the most informative interpretation of the available data and with an assessment of the implications of the information for future clinical studies.
The investigator brochure must be translated into the national language if the brochure is to be used in a country in which any site personnel is not sufficiently proficient in English or if the brochure is to be submitted to an ethics committee/IRB where it might be expected that some members are not sufficiently proficient in English.
MedTrans has years of experience helping its clients to translate concise and well-structured IBs into most languages and dialects. Our understanding of clinical development and its demanding timelines enables us to help clients plan and produce IBs promptly to support their ongoing clinical programs. A well-written IB that contains precisely the information needed relative to the current stage of development saves time on all fronts – for review by investigators and ethics committees as well as for the preparation of subsequent updates.
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