ICH E6

Veeva GCP for Clinical Trials

At the heart of every clinical trial is a participant who has volunteered to help advance medical science. Our primary duty is to ensure their rights, safety, and well-being remain at the forefront of every decision we make. By following Good Clinical Practice, we create a transparent and safe environment for enrollment and study conduct. Join us as we review the principles of informed consent, safety reporting, and the ethical standards that define modern clinical research.

CEU Credits: .1
Course Code: CEC-200
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 02/27/2026

Curriculum for this course

Course Introduction
Foundations Overview
GCP Principles
Getting Ready for the Trial
The Ethics Committee
The Investigator’s Brochure (IB)
Knowledge Check
The Informed Consent Process
Special Populations
Documentation
Randomization
Knowledge Check
Investigator Oversight and Delegation
Investigational Product (IP) Management
Safety Management
Oversight: Monitoring, Auditing, and Inspections
Knowledge Check
Data Integrity Foundations
The Data Life Cycle
Computerized Systems
Data Governance
Study Closeout
Compliance and Deviations
Termination of Trial Activities
Essential Records and the Archive
Study Closeout Conclusion
Knowledge Check
Summary

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