Introduction to Clinical Trial and Clinical Research Terminology

This course will provide a comprehensive introduction to the clinical trial process. Historical evolution of clinical research regulation will explain the implementation of laws associated with clinical research. Legislative and regulatory reforms to impose the safety, efficacy and ethical issues related to healthcare product development will be covered. Topics will include drug development and preclinical studies as well as different phases of clinical trials, protection of human subjects, brief introduction of the roles and responsibilities of clinical research teams and clinical research organizations. Students will also be introduced to basic medical and clinical research terminology including commonly used acronyms and abbreviations.