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The Basics of Clinical Data Management From Start to End


This one day face-to-face course will introduce participants to the basic principles of clinical data management.  Relevant information and instruction will be covered on data management to include, data capture instrument design, data editing, data tracking, metrics, and much more.  This interactive course will allow participants the opportunity to run through a series of hands on exercises.
Course Level: Beginner

What you will learn

  • How to develop a case report form
  • How to define a database structure and understand the various forms associated with database structures
  • Challenges and solutions related to the data entry process
  • How to check data to ensure proper quality
  • How to check and track study status and provide metrics to other functions


Who should attend?

Data management professionals with less than one year of pharmaceutical or related industry experience, including:

  • Study managers
  • Monitors / CRAs
  • EDC developers
  • Clinicians
  • Statisticians
  • Programmers
  • Project managers
  • Medical writers
  • Regulatory affairs professionals
  • Clinical safety and pharmacovigilance professionals

Learning objectives

At the conclusion of this course, participants should be able to:

  • Develop a case report form (CRF) based on a protocol and standards
  • Describe the setup of a database structure for the data capture and storage activities
  • Develop rules for data entry based on paper CRFs
  • Recognize how to create edit checks for data checking
  • Discuss and recognize how to keep an oversight on studies