Introduction to Clinical Research: Clinical Trial Phases and Design

This course provides a comprehensive introduction to trial phases and design for drug and medical device lifecycle development.

Students will build foundational knowledge in medical terminology, Good Clinical Practice (GCP), the responsibilities of investigators, sponsors, Clinical Research Organizations (CROs), and partners, as well as, the roles of the Food and Drug Administration (FDA), International Council for Harmonisation (ICH), Institutional Review Boards (IRBs), and Independent Ethics Committees (IECs).

Learners will gain practical skills in interpreting protocols, understanding operational workflows, and evaluating the structure and requirements of Investigational New Drug (IND) applications and device regulatory pathways.