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This e-learning course is tailored for professionals who possess a basic understanding of the International Council on Harmonization and Good Clinical Practice (ICH-GCP) guidelines but want to stay current. It serves as a comprehensive review and delves into the roles and responsibilities of all stakeholders in the clinical research industry. The course is designed to be interactive, with quizzes and exercises that provide instant feedback on your understanding. This approach allows for an optimized learning experience. To gauge your comprehension, there will be a final assessment, and additional resources, updates, and your recognized certification can be accessed on our learning platform.
In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Lesson 1: Introduction
Lesson 2: Definitions of key terms used in GCP
Lesson 3: The 13 principles of ICH-GCP (R2)
Lesson 4: Institutional review board (IRB)/ Independent Ethics Committee (IEC)
Lesson 5: Responsibilities of the investigator
Lesson 6: Responsabilities of the sponsor
Lesson 7: Clinical trial protocol and protocol amendments
Lesson 8: Investigator’s Brochure
Lesson 9: Essential Documents
Lesson 10: Septembre 2022- Upcoming revision 3 (R3) of ICH-GCP