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Module C: Clinical Trial Initiation and Implementation

X440.5 (2 semester units in Public Health)

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

This course module begins with a discussion of regulatory documents collection and upkeep by the sponsor or CRO. The focus then turns to processes of site initiation and investigator meetings; international regulations and issues inherent to global trials; subject enrollment and retention strategies; and an overview of routine site monitoring followed by examination of specific monitoring processes such as data review, drug accountability, and safety reporting. The final part of this module focuses on site and study close-out activities.

Prerequisites: Module A: Introduction to Clinical Research and Module B: Clinical Trial Planning and Preparation.

There are currently no sections open for enrollment.

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Sections closed for enrollment

Sat. Oct. 3, 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.

Revised class schedule in red.

• 4 meetings
• Oct. 3: Sat., 9 am-3 pm (no meetings Oct. 10 and Oct. 31); also
  Oct. 17: Sat., 9 am-1 pm
  Oct. 24: Sat., 9 am-4 pm
  Nov. 7: Sat., 9 am-5 pm
  
• San Francisco: Room 804, UC Berkeley Extension Downtown Center, 425 Market St., 8th Floor (enter on Fremont St.)
• $1,335 (EDP 401695)

Note: Class on Oct. 17 will meet in Room 809.

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