ICH E6

ICH E6 – Essential Documents (Chapter 8)(R2)

This course explores Essential Documents, Section 8 of ICH E6 R2 Good Clinical Practices (GCP). Knowing which Essential Documents are required and how best to prepare them will save you and your team time and contribute to the required compliance and success of your clinical trial.

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: 03/05/2023

Curriculum for this course

Course Introduction
54 secs
What You'll Learn
19 secs
What is an Essential Document?
8 secs
GDP and ALCOA
18 secs
Electronic Documentation
1 min 13 secs
Regulatory Binder and File
52 secs
Document Organization
41 secs
Subject Facing Material
21 secs
Agreements
1 min 38 secs
IRB and IEC Correspondence
1 min 13 secs
Regulatory
57 secs
Sponsor Communications
31 secs
Investigator Qualifications
17 secs
Laboratory
43 secs
Investigation Product Documents
1 min 12 secs
Enrollment
1 min 22 secs
Source Documentation
28 secs
Safety
1 min 2 secs
Quality
52 secs

Knowledge Check

In-Trial Documentation
15 secs
Trial Closeout Phase
27 secs
Post-trial Documentation
1 min 11 secs
Essential Document Retention
46 secs
Conclusion
44 secs
What We Covered
20 secs

Test Your Knowledge

Results

Revision History

Author

Nick Cohen

GxP Quality Assurance Expert

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