Good Clinical Practices (cGCP)

The Fundamentals of Good Clinical Practice (ICH E6 R3)

In this course we will discuss the fundamentals of Good Clinical Practices, or GCP. Good Clinical Practice sounds like an obvious part of any development, manufacturing, research or life science industry. However, this has not always been the case and not until relatively recently has there been an accepted and agreed upon standard for conducting clinical trials in a safe and ethical way. These issues, and many more, are the reason for the creation of Good Clinical Practices. So let’s take a journey through the history, roles and essential elements of Good Clinical Practice as laid out by ICH E6 R3.

CEU Credits: 0.1
Course Code: ELM-937
Duration: 25 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 01/23/2025

Curriculum for this course

Course Introduction
What is GCP?
Informed Consent and its Importance
Electronic Consent
History of Ethical Guidelines
The Nuremberg Code
Kefauver-Harris Drug Amendment
Declaration of Helsinki
The Belmont Report
IRB/IEC
Responsibilities and Functions
Documents and Records
Investigator
Definition and Purpose
Medical Care and Ethics
Communication and Compliance
Reports
Records
Final Thoughts on Investigators
Who is a Sponsor?
Sponsor Responsibilities
Additional Sponsor Responsibilities
Sponsor Overview
Data Governance
Data Lifecycles and Computerized Systems
Investigator’s Brochure
IB Components
How the IB is Used
Clinical Trial Protocol and Protocol Amendments
General Information and Trial Details
Trial Subjects and Assessments
Data and Quality Assurance
Additional Protocol Considerations
Essential Documents for the Conduct of a Clinical Trial
Why is GCP Important?
Conclusion
Test your knowledge
v1.0 Course released on 02/25/2025

Author

Nick Cohen

GxP Quality Assurance Expert

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