Biotechnology and Basic Sciences

A to Z Course Index

Information Sessions

Certificate Programs

Transcripts

Course Locations

Concurrent Enrollment

Order a Catalog

Courses begin every month. A new edition of our catalog is published three times a year in early April, July and December.

Quick Enroll	Search

Module A: Introduction to Clinical Research

X454 (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 and an elective in the Professional Sequence in Biotechnology Business and Marketing

This course begins with medical terminology and then introduces students to clinical trials with a discussion of clinical trial definition, the parties involved, and clinical trial processes and documents. The course then delves into a discussion of what Good Clinical Practice (GCP) means, clinical trial regulations and guidelines, and the roles of the FDA and the ICH. This is followed by a detailed look at the roles and responsibilities of investigators, ethical review boards and sponsors. As a sponsor responsibility, investigational new drug (IND) applications will also be discussed.

There are currently no sections open for enrollment.

---

Sections closed for enrollment

Sat. Sept. 12, San Francisco

MARIANNA 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
• Sept. 12-26: Sat., 9 am-1 pm (no meetings Sept. 19 and Oct. 3); also
  Oct. 10: Sat., 9 am-3 pm
  
• San Francisco: Room 805, UC Berkeley Extension Downtown Center, 425 Market St., 8th Floor (enter on Fremont St.)
• $1,335 (EDP 401661)

Quick Enroll	Search