Investigator’s Brochure

Investigator’s Brochure (IB): It 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.

Purpose of Investigator’s Brochure:

1. 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.

2. The IB also provides insight to support the clinical management of the study subjects during the clinical trial.

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.

The Investigator’s Brochure should include the following:

Title Page: This should provide the sponsor’s name, the identity of each investigational product (i.e., research number, chemical or approved generic name, and trade name(s) where legally permissible and desired by the sponsor), and the release date. It is also suggested that an edition number, and a reference to the number and date of the edition it supersedes, be provided.

Confidentiality Statement: The sponsor may wish to include a statement instructing the investigator/recipients to treat the IB as a confidential document for the sole information and use of the investigator’s team and the IRB/IEC.

Investigator's Brochure

Contents of the Investigator’s Brochure: The investigator’s brochure should contain the following sections, each with literature references where appropriate:

1. Table of Contents

2. Summary: Data and guidance for the investigator

3. Introduction

4. Physical, chemical, and pharmaceutical properties and formulation

5. Nonclinical studies 6. Effects in Humans

7. Summary of data and guidance for the investigator

2. Summary: A summary should be given on the significant physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical information for clinical development of the investigational product.

3. Introduction: A brief introductory statement should be provided that contains

  • Chemical name (and generic and trade name(s) when approved) of the investigational product(s).
  • All active ingredients.
  • Pharmacological class of investigational product and its expected position within this class (eg, advantages).
  • The rationale for performing research with the investigational product(s), and
  • The predictable prophylactic, therapeutic, or diagnostic indication(s).
  • The introductory statement should provide the general approach to be followed in evaluating the investigational product.

4. Physical, chemical, and pharmaceutical properties and formulation:

  • A description should be provided of the investigational product substance(s) (including the chemical and/or structural formula(e)).
  • A summary should be given of the relevant physical, chemical, and pharmaceutical properties.
  • Safety measures to be taken during the clinical trial,
  • Description of the formulation(s) to be used, including excipients, should be provided and justified if clinically relevant.
  • Instructions for the storage and handling of the dosage form(s) should also be given.
  • Any structural similarities to other known compounds should be mentioned.

5. Nonclinical studies: The information provided may include species tested, number and sex of animals in each group, unit dose (e.g., milligram/kilogram (mg/kg)), dose interval, route of administration, duration of dosing, results obtained. The following sections should discuss the most important findings from the studies;

(a)Nonclinical pharmacology: A summary of the pharmacological aspects of the investigational product studied in animals should be included. Such a potential therapeutic activity (eg., efficacy models, receptor binding, and specificity) and its safety.

(b) Pharmacokinetics and product metabolism in animals: A summary of the pharmacokinetics (local and systemic bioavailability) and biological transformation and disposition of the investigational product and its metabolites in all species studied should be given.

(c) Toxicology: A summary of the toxicological effects found in relevant studies conducted in different animal species should be described under the following headings where appropriate Single dose; Repeated dose: Carcinogenicity: Special studies (e.g., irritancy and sensitization): Reproductive toxicity; Genotoxicity (mutagenicity).

6. Effects on humans:

(a)Pharmacokinetics information should be presented as follows:

  • ADME, and plasma protein binding,
  • Bioavailability of the investigational product using a reference dosage form.
  • Population subgroups (e.g., gender, age, and impaired organ function). Interactions (e.g.. product-product interactions and effects of food).
  • Other pharmacokinetic data (e.g., results of population studies performed within a clinical trial(s)).
  • Product metabolism in humans

(b) Safety and efficacy information should be provided about the following:

  • Investigational products safety, pharmacodynamics, efficacy.
  • Dose-response obtained from clinical trials in humans (healthy volunteers and/or patients).
  • Adverse drug reactions (ADRs) for all the clinical trials.
  • Important differences in ADR patterns/incidences across indications or subgroups should be discussed.
  • A description of the precautions or special monitoring to be done as part of the investigational use of the product(s).

(c) Marketing experience: The IB should identify countries where the investigational product has been marketed or approved. Any significant information arising from the marketed use should be summarized (e.g.. formulations, dosages, routes of administration, and adverse product reactions). The IB should also identify all the countries where the investigational product did not receive approval/registration for marketing or was withdrawn from marketing/registration.

7. Summary of data and guidance for the investigator: This section should provide an overall discussion of nonclinical and clinical data. Where appropriate, the published reports on related products should be discussed. The overall aim of this section is to provide the investigator with a clear understanding of the possible risks and adverse reactions, and of the specific tests, observations, and precautions that may be needed for a clinical trial.

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