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: 12/01/2023

Curriculum for this course

Course Introduction

Course Introduction

45 secs

What You'll Learn

15 secs

IB Overview and Structure

Document Overview

2 min 15 secs

How the IB is Used

30 secs

Check Your Knowledge

30 secs

IB Sections and Content

Document Structure and Format

1 min 15 secs

Physical Chemistry

1 min

Nonclinical Research

1 min

Nonclinical Research - Pharmacology

1 min

Nonclinical Research - Toxicology

1 min

Clinical Research

30 secs

Clinical Research - Pharmacology

45 secs

Clinical Research - Safety and Efficacy

30 secs

Clinical Research - Marketing Experience

30 secs

Appendices

15 secs

Check Your Knowledge

30 secs

Conclusion

What We Covered

15 secs

Test Your Knowledge

Results

Author

Nick Cohen

GxP Quality Assurance Expert

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