Clinical Science Course

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 8AM - Wednesday 4:30PM.

Module 2 is the Medical / Scientific Module consisting of sessions pertaining to: Ethical Issues in Clinical Trials, Anatomy and Physiology, Cell Biology, Genetics, Clinical Laboratory Analysis, Epidemiology, andResearch Statistics.

Module 2 is a 2 1/2 day course which meets Wednesday 1PM - Friday 4:30PM.