This foundational course provides a
comprehensive overview of the International Council for Harmonization Good
Clinical Practice (ICH GCP E6 R3) guidelines, which form the global ethical and
scientific standard for designing, conducting, recording, and reporting
clinical trials involving human subjects. Participants will gain an in-depth
understanding of the core principles, including the protection of human rights,
the assurance of safety and well-being for trial participants, and the
integrity of clinical trial data. Through practical scenarios, you will learn
to apply these critical regulations to ensure compliance, maintain rigorous
ethical standards, and contribute to the generation of reliable and defensible
clinical research outcomes.