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Fundamentals of Clinical Trials

A required course for the Certificate Program in Clinical Trials: Medical Device and Drug Development and a required course in the Certificate Program in Regulatory Affairs and Compliance.

Course Description

Clinical trials are designed to answer questions concerning the safety and effectiveness of medical products. Get an overview of clinical trials regulated by the FDA. Learn about the planning process underlying the Strategic Clinical Plan and regulatory submissions to the FDA. Explore topics including protocol development and implementation, i.e. study site selection, financial controls, timelines, and management of the site's operations; proper informed consent; Good Clinical Practices compliance; HIPAA; FDA regulations and guidelines; and post-market support studies.

Provider approved by the California Board of Registered Nursing, Provider Number 00093, for 30 contact hours.

  • Details
  • $735
  • January 10, 2022 to March 20, 2022
  • Delivery Mode: Online
  • Reg#: 00156
  • ID/Units: BIO SCI X450  (3.00)
    ( Section 1 )
  • Quarter: WINTER 2022


Pukar Ratti, MSChE, MSHCM, CIM, CCRP, FACMPE, is the Executive System Director of Research at CHRISTUS Health in Dallas area. Prior to that, he has worked as Director of Clinical Research and Biobank at Ochsner Health System in New Orleans, and the Department Head of the Office of Research & Sponsored Projects at Leonard J. Chabert Medical Center, part of the Louisiana State University Health System. Pukar has over 15 years of combined experience in Research Administration, Clinical Research, Pre-clinical/Basic Science Research, Behavioral Research, Clinical Research Revenue Cycle, Project Management, IRB services, Contract negotiations, Student Mentorship, Operational Redesign, Grants Portfolio Management, Policy-making, Personnel Development, Strategic Planning, Biobanking, etc. Today, Pukar is one of the few medical professionals in the State of Texas to have earned the prestigious title of Fellow of American College of Medical Practice Executives.

Textbook Information

Textbooks for your course may be purchased from any vendor or bookseller of your choice.

No textbooks are required for this course.

Meeting Schedule

EventDateDayStart TimeEnd TimeLocationRoom
START01/10/2022Monday------Online (Access Begins)---
END03/20/2022Sunday------Online (Access Ends)---