Good Clinical Practices (cGCP)

ICH E6 – Clinical Trial Protocol and Protocol Amendments (Chapter 6) (R2)

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.

The objective is to provide a unified standard for the EU, Japan, and US to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

This course explores the standard clinical protocol and related documents we use to comply with GCP.

By the end of this course, you should be able to:

  • Identify clinical trial protocol requirements.
  • Define protocol compliance.
  • Provide examples of optional and related protocol documents.
  • Describe the clinical trial protocol structure.
  • Discuss the expected information to be included in each individual protocol section.
Book a Demo
CEU Credits: 0.1
Course Code: ELM-915
Duration: 15 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 11/23/2022

Curriculum for this course

Course Overview
What You'll Learn
Definitions
Other Documents
Transfer of Obligations
Section 6.1: General
Section 6.2: Background Information
Section 6.3: Trial Objectives
Section 6.4:Trial Design
Section 6.5: Selection and Withdrawal of Subjects
Section 6.6: Treatment of Subjects
Section 6.7: Efficacy Assessments
Section 6.8: Safety Assessments
Section 6.9: Statistical Analysis
Section 6.10: Direct Access to Source Data
Section 6.11: Quality Control and Quality Assurance
Section 6.12: Ethics
Section 6.13: Data Handling and Recordkeeping
Section 6.14: Financing and Insurance
Section 6.15: Publication Policy
Section 6.16: Supplemental Sections
What We Covered
Test Your Knowledge
Results
v1.1 Minor update on 05/22/2025 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 01/12/2023

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