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Module A: Introduction to Clinical Research

X454 (2 semester units in Public Health)

30 hours CE credit: BRN provider #00226

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.

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Sat. June 7, San Francisco