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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.
Instructor
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 9781439848296
Meeting Schedule
Event Date Day Start Time End Time Location Room
START 04/03/2023 Monday --- --- Online (Access Begins) ---
END 05/14/2023 Sunday --- --- Online (Access Ends) ---