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

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Effective Date: 01/12/2023

Curriculum for this course

Course Introduction

Course Introduction

What You'll Learn

IB Overview and Structure

Document Overview

How the IB is Used

Check Your Knowledge

IB Sections and Content

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

Conclusion

What We Covered

Test Your Knowledge

Results

Author

Nick Cohen

GxP Quality Assurance Expert

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