Fundamentals of Clinical Research

New to the field or need to brush up on the fundamentals? This course is for you.

This two-day seminar, worth 12 contact hours/credits, will focus on the fundamentals of professionally conducted clinical research trials. Fundamentals of Clinical Research is designed for those who aspire to the following roles: clinical research professionals managing studies at clinical research sites or monitoring studies, product managers, clinical investigators, institutional review board members, clinical pharmacologists, and research pharmacists. Enrollment is limited to 50 participants.

Upcoming Dates & Locations

• Arlington - Sept. 4-5, 2008
• Houston - Oct. 16-17, 2008

Course Objectives

Upon successful completion of this course, participants should be able to:

• Discuss historical events leading to the regulation of medical product development.
• Discuss principles of Good Clinical Practice (GCP).
• Explain the drug development process.
• Compare and contrast drug and device research.
• Identify current regulatory and ethical issues in clinical research.
• Describe the process for obtaining informed consent.
• Define the regulatory reporting requirements for adverse experiences.