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The Basics of Clinical Data Management From Start to End

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Overview 

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

Contact Information 

Jessica McGrory at +1-215-442-6182 or Jessica.McGrory@diahome.org

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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