Clinical Trials and Research Regulations
Prerequisites: CRC 1103
The student will receive and overview of federal and international guidelines governing clinical research and drug trials, including Good Clinical Practices and International Council on Harmonization guidelines. An emphasis will be placed on understanding of research organization compliance, responsibilities of the Internal Review Board and the Health Insurance Portability and Accountability Act (HIPAA). The student will identify and complete required regulatory forms, define human subject protection guidelines, compare federal versus international guidelines for clinical research and discuss conflict of interest issues.