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