Good Clinical Practices (cGCP)

ICH E6 – Investigator’s Brochure (Chapter 7) (R2)

The Investigator’s Brochure is a document that describes all known physical characteristics, chemical characteristics, nonclinical (or animal), testing and clinical (or human) testing for an Investigational Product, known to date. The IB is a “living” document frequently updated throughout an Investigational Product’s development lifecycle. As more research is completed, the results are added to the IB.

This course is divided into two sections:

  • IB overview and structure
  • IB sections and content 
CEU Credits: 0.1
Course Code: ELM-916
Duration: 15 mins
Skill Level: Basic
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 01/12/2023

Curriculum for this course

Course Introduction
What You'll Learn
Document Overview
How the IB is Used
Check Your Knowledge
Document Structure and Format
Physical Chemistry
Nonclinical Research
Nonclinical Research - Pharmacology
Nonclinical Research - Toxicology
Clinical Research
Clinical Research - Pharmacology
Clinical Research - Safety and Efficacy
Clinical Research - Marketing Experience
Appendices
Check Your Knowledge
What We Covered
Test Your Knowledge
v1.1 Minor update on 05/09/2025 Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.
v1.0 Course released on 04/17/2023