Good Clinical Practices (GCP)

• The Center for Professional Innovation & Education

Upon completion of this course, each participant will have a thorough understanding of GCPs dictated by FDA and ICH Requirements for Sponsors, Monitors, and Investigators. In addition, the significance of these regulations will be correlated to protocol and case report form development for all phases of clinical research. Information regarding in-field and in-house auditing (i.e., Quality Assurance (QA) procedures compared to FDAs Bio-monitoring system) will be presented. Investigational Review Boards (IRBs) and Informed Consent (IC) as required by the FDA and ICH regulations are discussed in detail and are compared with GCP and ICH regulations.