Annual Refresher Training

Good Clinical Practice Refresher 2026

Good Clinical Practice or GCP is important to ensure that clinical trials are conducted ethically and that the data generated is reliable, upholding the rights and safety of participants. In this course, learners will navigate scenarios related to the updated principles and themes of ICH E6 R3, including risk-based approaches, data governance, and an increased focus on the participant. In each, learners will take the point of view of a character and make a critical choice on what they should do in a difficult situation.

CEU Credits: 0.1

Course Code: ELM-991

Duration: 10 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: v1.0

Effective Date: 01/01/2026

Curriculum for this course

Welcome

Review of Good Clinical Practice (GCP)

Course Introduction

Instructions

Choose a Scenario

Scenario 1: Unclear Roles

The Delegation Log

Training Deficiency

Explanation

Scenario 2: Informed Consent

Consent and Assent Processes

Explanation

Scenario 3: Remote Monitoring

The Site’s Proposal

The Data Transfer

Explanation

Conclusion

Revision History

v1.0 Course released on 01/27/2026

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