Investigator’s Brochure (IB) is a document which contains all the available clinical and non-clinical data on the Investigational Product(s) that are known and relevant to the study of the product. The IB provides investigators and others involved in the study with information on the rationale in order to facilitate compliance with the key features of the Protocol dose, frequency and interval of the dose, methods of administration and safety monitoring procedures. It also provides background material to support the clinical management of the study participants. There should be adequate data to justify the nature, scale and duration of the proposed trial and to evaluate the potential safety and need for special precautions. If new substantially relevant data is generated during the trial, the information in the IB must be updated. The information included in the investigator’s brochure should be concise, simple, objective, balanced, non-promotional, enable an unbiased understanding, and facilitate a risk benefit assessment for the appropriateness of the proposed trial.
It is recommended that a medically qualified individual be involved in the development and editing of an IB. However, the content should be approved by the appropriate discipline (that generated the data). The elements that should be included in the IB are:
- Administrative details: including the title of the trial, reference number, details of the Investigational Product (IP) and details of version control.
- It is essential that the IB includes a confidentiality statement.
- Introduction: information that is relevant to the clinical development of the IP.
- Physical, Chemical and Pharmaceutical properties and formulation parameters of the IP.
- Information from non-clinical studies
- Effects in humans including pharmacokinetics and product metabolism in humans, safety and efficacy, regulatory and post-marketing experience
- Summary of data and guidance for the investigator
It is also advisable to revise the IB as per the Sponsor’s SOP. Any new information that is considered important, should be communicated to the Investigator(s), EC and regulatory authorities immediately. This should be done even before the information has been included in the IB.
This template can be used to develop an Investigator’s Brochure.
- Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2001, available online (last accessed on 26.02.2019).
- New Drugs and Clinical Trial Rules, 2019, G.S.R. 227(E), Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, available online (last accessed on 01.04.2019).
- ICH Harmonised Guideline, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), current step 4 version, dated 9th November 2016, available online (last accessed on 26.02.2019).