Module B: Clinical Trial Planning and Preparation
X440.1 (2 semester units in Public Health)
30 hours CE credit: BRN Provider # 00226
This course reviews the processes and procedures of planning and preparing for clinical trials. Topics include protocol development, with a review of the development process; types of case report forms (CRFs) and their design; and informed consent including its elements, documentation, exceptions, and emergency research. You learn about selecting investigational sites and conducting prestudy site visits. Site contracts, budget development, and finalization are also reviewed and discussed.
Prerequisite: Module A: Introduction to Clinical Research.
There are currently no sections open for enrollment.
Sections closed for enrollment
Sat. April 19, San Francisco
KAREN HENRY, M.P.H., has held the roles of manager of data management, statistician, trial monitor, trial manager, manager of SOP development and clinical trials training, and instructor. Her participation has been in all phases of drug, biologics, and diagnostic trials in various therapeutic areas, and on the side of the sponsor and investigator. Her past employment has been with New York State Psychiatric Institute/Columbia Presbyterian Medical Center, UC San Francisco Medical Center, Berlex Laboratories, and Chiron Corporation. She currently works for a start-up company as manager of clinical operations. She holds a master's of public health in biostatistics from Columbia University.
MARYANN LENOCI, M.A., serves at the senior project director for the Posttraumatic Stress Disorder (PTSD) Research Core of the Mental Illness Research, Education and Clinical Center (MIRECC) at the San Francisco Veterans Affairs Medical Center. She has 10 years of experience managing a number of VA, U.S. Department of Defense, National Institutes of Health, and industry-funded research studies in the area of PTSD.
- 3 meetings
- April 19: Sat., 9 am-4 pm (no meetings April 26 and May 10); also
May 3: Sat., 9 am-4 pm
May 17: Sat., 9 am-5 pm
- San Francisco: Room 813, UC Berkeley Extension Downtown Center, 425 Market St., 8th Floor (enter on Fremont St.)
- $1,250 (EDP 403188)
Courses begin every month. A new edition of our catalog is published
three times a year in early April, July and December.