This five day intensive course provides a solid foundation in the principles upon which clinical trials are based. Topics include: drug development process, device development, GCPs (ICH and FDA), Case Report Form design, investigator selection, IRBs/informed consent, trial design & protocol, site and study management, monitoring, regulatory issues, and data analysis. Light refreshments are provided daily, and on Monday only, a light luncheon is provided so students and instructors can get acquainted.
Note: Intensive Workshop may be taken alone, or as Part 1 of Specialized Certificate in Clinical Trials Administration. Part 2 includes three online courses and a follow-on workshop. Contact Donna Stern at firstname.lastname@example.org for more information on the Specialized Certificate program.
Other Credit: BRN: 40 CE hours
Course Number: FPM-40273 Credit: 4 units