Clinical Research / Clinical Science Course

Goal: This course has been established to develop an internationally accepted standard of knowledge and understanding of the research process and related regulations, as well as medical and scientific areas related to clinical research. Objective: The course contains two modules. 35 hours total CE available. The attendee may elect to attend one (either) or both modules. Module I is the Regulatory / Procedural Module consisting of sessions pertaining to: Issues Involved in Addressing the Development Process, Clinical Pharmacology and Adverse Event Reporting, Study Development and the Research Budget, Good Clinical Practices, ICH Guidelines, Informed Consent, Preparing for an GCP Audit, Regulatory Affairs and IRBs (IND/NDA), Research Ethics, and Source Documentation and Administration. Module 1 is a 3 day course which meets Monday 8:00 a.m. - Wednesday 4:30 p.m. Module 2 is the Medical / Scientific Module. It is focused on Medicine and Science, designed for those who are relatively new to research who wish to strengthen their understanding of medicine and science. Module 2 consists of sessions pertaining to: Ethical Issues in Clinical Trials, Anatomy and Physiology, Cell Biology, Genetics, Clinical Laboratory Analysis, Epidemiology, and Research Statistics. Module 2 is a 2 1/2 day course which meets Wednesday 1:00 p.m. - Friday 4:30 p.m