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Introduction to Clinical Data Management

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Overview 

This course reviews processes and activities that illustrate the relationship between clinical data management and drug development.

What You Will Learn 

  • Data management processes and activities
  • The role of data management in clinical research
  • What to expect from inspections of clinical data management operations
  • Industry initiatives to develop independent, global standards to support the improvement of data quality
  • Communication, standardization, and documentation

Who Should Attend 

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

  • Clinical researchers
  • Clinicians
  • Statisticians
  • Programmers
  • Project managers
  • Medical writers
  • Regulatory affairs professionals
  • Clinical safety and pharmacovigilance professionals

Learning Objectives 

Participants who complete this training should be able to:

  • Describe regulatory agencies, guidelines and what to expect for inspections of clinical data management operations
  • Discuss data management challenges and how they relate to the drug development process
  • Recognize the industries global standards that support improvement of data quality
  • Explain the importance of communication, standardization and documentation

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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