GCDMP Revision Session

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Electronic Data Capture (EDC) – Chapeter 1

Friday 8 March 2019

5:00 – 6:30 PM CET

OVERVIEW

Electronic Data Capture (EDC) is being utilized as a preferred method for “real time” data capture by sponsors of clinical trials.  This chapter reviews the considerations for selecting an EDC system such as evaluation of systems, user requirements, process changes and implementation of systems, to identify the needs and requirements, thus ensuring a comprehensive study application.  Multiple users on study teams use the EDC system and, therefore, should be involved in software selection.

CHAPTER GOALS

After reading this chapter, the reader should understand:

  • The regulatory basis for practices in selecting an EDC system
  • Common requirements and functionality domains of EDC systems
  • Key domains and criteria for pre-selection evaluation of EDC systems
  • Process impact and redesign considerations at evaluation and selection time
  • Initial system implementation within an organization

AGENDA

  • Good Clinical Data Management Practice (GCDMP) EDC Chapter Updates
  • EDC Considerations
    • EDC Product Features and Integrations
    • Methods of Delivery
    • Business Requirements
    • Selecting and Contracting
  • How to provide feedback