INVESTIGATOR'S BROCHURE as per ICH E6 (ICH GCP)

1. INVESTIGATOR’S
BROCHURE

2. ICH GCP & INDIAN GCP
ICH GCP INDIAN GCP
Glossary Definitions
Principles Pre – requisites
IRB/IEC Responsibilities
Investigator Records & Data
Sponsor Quality Assurance
Protocol Statistics
Investigator’s Brochure Special Concerns
Essential Documents Appendices

3. INDIAN GCP
1. Definitions
2. Pre-requisites for the study
2.1 Investigational Pharmaceutical Product
2.2 Pre-Clinical supporting data
2.3 Protocol
2.4. Ethical & Safety Considerations
3. Responsibilities
3.1. Sponsor
3.2. The Monitor
3.3. Investigator

4. 4. Record Keeping and Data Handling
4.1. Documentation
4.2. Corrections
4.3. Electronic Data Processing
4.4. Validation of Electronic Data Processing
Systems
4.5. Language
4.6. Responsibility of Investigator
4.7. Responsibilities of Sponsor and Monitor

5. 5. Quality Assurance
6. Statistics
6.1. Role of Biostatistician
6.2. Study design
6.3. Statistical Analysis
7. Special Concerns
7.1. Clinical Trials of Vaccines
7.2. Clinical Trials of contraceptives
7.3. Clinical Trials with Surgical Procedures
/ Medical devices.
7.4. Clinical Trials for Diagnostic agents –
Use of radioactive materials and
7.5. Clinical Trials of Herbal Remedies and
Medicinal Plants

6. 8. Appendices
Appendix I Declaration of Helsinki
Appendix II Schedule Y
Appendix III Format for submission of Pre-
clinical and clinical data for r-
DNA based vaccines,
diagnostics and other
biologicals.
Appendix IV Investigator’s Brochure
Appendix V Essential Documents

7. Investigator’s Brochure
 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.

8. Purpose of I.B.
 Its purpose is to provide Information
to the Investigators and others
involved in the trial 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 and simple manner

9. Purpose of I.B
 I.B. 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

10. Contents of I.B
 The Investigator Brochure should
include:
1) Title Page
A. Sponsor name
B. 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),
C. The Release Date.
D. Confidentiality Statement

11. CONTENTS OF IB
1. Table of contents
2. Summary – not exceeding 2 pages.
highlighting the significant physical,
chemical, pharmaceutical,
pharmacological, toxicological,
pharmacokinetic, metabolic, and clinical
information available of IP
3. Introduction:
chemical name, active ingredients,
pharmacological class, anticipated –
therapeutic/ diagnostic indication(s).
General approach to be fallowed in
evaluating the IP

12. 4. Description of I.P. Physical, Chemical
and pharmaceutical properties of I.P.
Storage and handling of I.P.
Any structural similarity with the other
known compound given.

13. 5. Non clinical studies
 The results of all relevant nonclinical
pharmacology, toxicology,
pharmacokinetic, and investigational
product metabolism studies should be
provided in summary form.
 The information provided may include:
 Species tested,
 Number of sex in each group
 Unit dose (e.g., milligram/kilogram (mg/kg),
 Dose interval,
 Route of administration and
 Duration of dosing.

14. 5.1 NON CLINICAL PHARMACOLOGY:
A summary of the pharmacological aspects of
the investigational product studied in
animals, should be included.
5.2 PHARMACOKINETICS AND PRODUCT
METABOLISM IN ANIMALS
A summary of the pharmacokinetics(ADME)
and biological transformation and
disposition(getting a drug into its appropriate
position in the body and in an appropriate
concentration) of the investigational product
in all species studied should be given.

15. 5.3 TOXICOLOGY
(The study of the adverse effects of chemicals on
animals)
 A summary of the toxicological effects found in
relevant studies conducted in different animal
species.
 Single dose
 Repeated dose
 Carcinogenicity
 Special studies (irritancy, sensitisation)
 Reproductive toxicity
 Genotoxicity (mutagenecity)

16. 6. EFFECTS IN HUMANS
 A thorough discussion of the known effects of the
investigational product(s) in humans should be provided,
including information on pharmacokinetics, metabolism,
Pharmacodynamics, dose response, safety, efficacy, and
other pharmacological activities.
(a) Pharmacokinetics and Product Metabolism in Humans
A summary of information on the pharmacokinetics of the
investigational product(s) should be presented.
(b) Safety and Efficacy: A summary of information should be
provided about the investigational product's safety,
efficacy, pharmacodynamics
(c) Marketing Experience: The IB should identify countries
where the investigational product has been marketed or
approved.

17. 7. Summary of Data and Guidance for the
Investigator
This section should contain nonclinical and clinical
data of IP.
 IB – provide the investigator a clear
understanding of
 The possible risks
 Adverse reactions
 Observations & precautions needed for the clinical
trial.