Clinical Research Regulations

Catalog description

Overview of legal and regulatory research compliance. Federal and international regulations, Good Clinical Practice (GCP) and International Council on Harmonization (ICH) guidelines. Roles, responsibilities and related regulations of Institutional Review Boards (IRB), Data Monitoring Boards and research organizations. Required forms, human subject protection, research integrity, ethical considerations, Health Insurance Portability and Accountability Act (HIPAA) and conflict of interest issues. Prerequisites: None.