Good Clinical Practices (cGCP)

Sponsor Oversight of Outsourced Trials

The landscape of clinical research is undergoing its most significant transformation in a generation. ICH E6(R3) has been developed to be a flexible and “future-proof” framework. In this course, learners will explore three pillars of modern clinical trial oversight and the common systems that can be used to support them.

CEU Credits: 0.1

Course Code: ELM-997

Duration: 15 mins

Skill Level: Intermediate

Final Exam: Yes

Certification: Yes

Version: v1.0

Curriculum for this course

Welcome

Beyond a “One-Size-Fits-All” Approach

Delegation and Accountability

The Three Pillars of Modern Sponsor Oversight

Quality Management

Quality by Design

Critical-to-Quality Factors

Tools to Support Quality

Risk-Based Approaches

Risk-Based Quality Management

A Modern, Flexible Monitoring Strategy

Risk Management Plan

Risk Management Tools

Governing the Digital Trial

Essential Records

Sponsor Oversight of Computerized Systems

Data Life Cycle

Essential Records Systems

Conclusion

Summary

Test your knowledge

Revision History

v1.0 | Course released on 06/30/2026.

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