ICH E6

ICH E6 – Investigator (Chapter 4) (R2)

Upon completing this course, you will be able to define what an Investigator is and what their responsibilities are, discuss typical clinical research site requirements that an investigator is responsible for, provide examples of how the Investigator interacts with sponsors, regulators, and their IRB and identify the requirements and process for informed consent and assent.

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CEU Credits: 0.1
Course Code: ELM-906
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: v1.2
Effective Date: 03/30/2023

Curriculum for this course

Course Introduction
What You'll Learn
What an Investigator Does
Clinical Trial Site Leaders
Investigator Qualifications
Staffing and Resourcing
Common Site Research Stall
Medical Oversight
Knowledge Check
IRB/IEC Engagement
Compliance
Failure to Comply
IMP Management
IMP Accountability
Randomization and Blinding
Informed Consent Overview
Non-Therapeutic Trials
Records and Reports
Safety Reporting
Trial Termination
Final Report
Conclusion
What We Covered
Test Your Knowledge
v1.2 Minor update on 7/31/2025 Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed. One question in the quiz was updated to more accurately reflect the assent process.
v1.1 Minor update on 04/29/2024 to update description of assent in the course and changes references of “IFC” to “ICF”
v1.0 Course released in 09/2023

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