CEU Credits: 0.1
Course Code: ELM-917
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 05/03/2023
Curriculum for this course
Course Introduction
What You'll Learn
What is an Essential Document?
GDP and ALCOA
Electronic Documentation
Regulatory Binder and File
Document Organization
Subject Facing Material
Agreements
IRB and IEC Correspondence
Regulatory
Sponsor Communications
Investigator Qualifications
Laboratory
Investigation Product Documents
Enrollment
Source Documentation
Safety
Quality
Knowledge Check
In-Trial Documentation
Trial Closeout Phase
Post-trial Documentation
Essential Document Retention
Conclusion
What We Covered
Test Your Knowledge
Results
Revision History
