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Clinical Data Management

An elective course in the Certificate Program in Clinical Trials: Medical Device and Drug Development.

Course Description

Learn about the handling, processing, storage, retrieval, and electronic submissions of clinical data. Gain an understanding of the issues and implications surrounding database setup and the data management process. Enhance your knowledge of applicable FDA regulations (Part 11), and guidelines and the documentation necessary to achieve FDA compliance. The course will be of interest to clinical data management professionals, clinical research coordinators, clinical research associates, project managers, and programmers who support the design and development of clinical databases.

Prerequisite: Knowledge of the medical product development process, including a basic understanding of clinical trials and the role of the FDA. 

Provider approved by the California Board of Registered Nursing, Provider Number 00093, for 15 contact hours.

  • Details
  • $550
  • April 03, 2023 to May 14, 2023
  • Delivery Mode: Online
  • Reg#: 00214
  • ID/Units: MED X413.43  (1.50)
    ( Section 1 )
  • Quarter: SPRING 2023


Jody Schulz, M.S., is a clinical trial and process improvement expert who has worked in healthcare since 2000. She has worked in clinical research managing clinical trials in the United States and Europe for investigational devices/pharmaceuticals for physicians, surgeons, and medical device companies. She also received her Lean Six Sigma Black Belt from UCI to further expand process improvement efforts related to clinical research and healthcare. Her expertise is supported by a B.S in Healthcare Administration and an M.S. in Biology. She enjoys being a resource to students interested in learning more about her areas of expertise.

Textbook Information

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

Required Textbook(s):

Practical Guide to Clinical Data Management
Book - ISBN: 9781439848296
Susanne Prokscha , 3 ed, CRC PRESS

Meeting Schedule

EventDateDayStart TimeEnd TimeLocationRoom
START04/03/2023Monday------Online (Access Begins)---
END05/14/2023Sunday------Online (Access Ends)---