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Fundamentals of Clinical Trials

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

Course closed to new registrations: Call ( 949 ) 824-5414 for more information or sign up below to be notified when this course becomes available.×

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.

  • Be notified when this class becomes available!

  • Details
  • $735
  • January 08, 2024 to March 17, 2024
  • Delivery Mode: Online
  • Reg#: 00097
  • ID/Units: BIO SCI X450  (3.00)
    ( Section 1 )
  • Quarter: Winter 2024

Instructor


Pukar Ratti, MSChE, MSHCM, CIM, CCRP, FACMPE, currently serves as the System Director for Research Administration at Texas' largest healthcare system- Baylor Scott & White Health in Dallas, Texas. Since 2002, he has held research appointments at prominent Health Systems such as CHRISTUS Health, Ochsner Health, Louisiana State University Health, and University of South Alabama Health. In his parallel teaching career track since 2010, has been an instructor at University of California Irvine (current), teaching at Keck Graduate Institute (current), Rutgers University (past), University of Phoenix (past), and Dillard University (past). Additionally, Pukar has served as an Institutional Review Board (IRB) member on Ochsner Clinic Foundation’s IRB, has numerous peer-reviewed manuscripts to his credit, and is a frequent speaker at national conferences and major academic meetings. With multiple graduate degrees in Healthcare Management, Biochemistry and Chemical Engineering, plus active certifications as CCRP from SoCRA, CIM from NAIL, and FACMPE fellowship from MGMA, Pukar has over 21 years of combined experience in Research, Academics, Biobanking, and Teaching. In 2019, he was humbly honored with the ‘Distinguished Instructor’ Award from UCI.

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
START01/08/2024Monday------Online (Access Begins)---
END03/17/2024Sunday------Online (Access Ends)---