Introduction to Clinical Research

Catalog description

Introduction to the clinical research process. History, development and basic study designs in varied health, biomedical and biotechnical settings. Clinical trial development phases and regulatory protection for human subjects. Roles and responsibilities of the clinical research team and research organization. Good Clinical Practice (GCP) and International Committee on Harmonization (ICH) guidelines. Functions, research terminology, and general research funding of the Institutional Review Board (IRB) and Ethics Review Committee. Prerequisites: None.