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Module B: Clinical Trial Planning and Preparation

X440.1 (2 semester units in Public Health)

30 hours CE credit: BRN Provider # 00226

A required course in the Professional Program in Clinical Research Conduct and Management

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 and budget development and finalization are also reviewed and discussed.

Prerequisite: Module A: Introduction to Clinical Research.

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Sat. Nov. 14, San Francisco

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
• Nov. 14 to Dec. 5: Sat., 9 am-4 pm (no meetings Nov. 21, Nov. 28, and Dec. 12); also
  Dec. 5: Sat., 9 am-4 pm
  Dec. 19: Sat., 9 am-5 pm
  
• San Francisco: Room 807, UC Berkeley Extension Downtown Center, 425 Market St., 8th Floor (enter on Fremont St.)
• $1,335 (EDP 401653)

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Textbook(s) for this course:
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