Good Clinical Practice (GCP)

This course introduces participants to the fundamental ethical and scientific principles that guide Good Clinical Practice (GCP) in clinical research. Based on the International Conference on Harmonisation (ICH) E6(R2) guidelines, the course ensures that learners gain the skills necessary to design, conduct, record, and report clinical trials involving human participants ethically and in compliance with regulatory expectations.

Course Objectives

By the end of this course, participants will be able to:

1. Explain the concept and scope of Good Clinical Practice as a global standard for ethical and scientific quality in clinical research.

2. Articulate the foundational ethical and procedural principles that underpin the GCP framework.

3. Describe what it means to be trained in GCP and why such qualification is essential for research integrity and participant safety.

4. Outline the key obligations of investigators in the design, conduct, and oversight of clinical trials.

5. Demonstrate how GCP guidelines are applied throughout the research lifecycle, from protocol development to data reporting.

6. Reflect on the role of GCP in fostering trust, regulatory compliance, and high-quality data in human subject research.

Upon successful completion (≥80% score on the final assessment), participants will receive a GCP certificate, acknowledging their competence to participate in or support clinical trials to global standards.

Note: Accessible only to authorised users (Members only)