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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. 

Other Credits: BRN: 40 CE hours

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 Debbie Ortuño at for more information on the Specialized Certificate program. Students must enroll in both parts of the program in the same quarter to be eligible for the Specialized Certificate.  

The spring 2024 course starts with a 5-day Intensive Workshop: Monday – Friday, 4/15/24 - 4/19/24, via live Zoom format. (8:30 a.m. to 4:30 p.m. PST).

Course Number: FPM-40273
Credit: 4.00 unit(s)
Related Certificate Programs: Clinical Trials Administration