ICH E6

ICH E6 (R3) – Sponsor

Clinical trials can range from a relatively small operation to a massive undertaking. With all the moving pieces and integral parts of a trial, qualified and capable management is integral in order to be successful. That’s where a sponsor comes in. In this course, you will learn the responsibilities of the sponsor according to ICH E6 (R3), reviewing small portions of the obligations at a time and recognizing how these duties may apply to their own trials.

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CEU Credits: 0.1
Course Code: ELM-980
Duration: 25 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 04/30/2025

Curriculum for this course

Course Introduction
Introduction to ICH E6 (R3)
Sponsor Overview
Overview of Sponsor Presence & Oversight
Sponsor Oversight
Sponsor-Investigators
Trial Design
Investigator Selection
Personnel Qualification & Training
Regulatory Authorities
Safety Assessment and Reporting
Key Operational Entities
Allocation and Transfer of Responsibilities
Trial Management
Financing and Agreements
Compensation to Participants
Quality Management
Risk Areas
Risk Scenario
Quality Control vs. Quality Assurance
Quality Control Activities: Monitoring
Quality Assurance Activities: Auditing
Noncompliance
Data and Records
Reporting Responsibilities
Summary
Test your Knowledge!
V1.0 Course released on 07/29/2025

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