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Clinical Data Management

Clinical data management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management assures collection, integration and availability of data at appropriate quality and cost.

#Course Content: (Course code: GAC003)

CLINICAL DATA MANAGEMENT

  • Data management plan
  • Study set up
  • Tracking CRF Data
  • Entering data
  • Managing lab data
  • Identifying and Managing discrepancies
  • Collecting adverse Event Data
  • Where systems come from?
  • Choosing vendor products
  • Implementing New Systems
  • System Validation
  • Test plans
  • Migrating legacy Data
  • Change control
  • Creating hierarchies
  • Sops and guidelines
  • Working with CROS
  • CRF Design Consideration
  • Remote Data Entry
  • Auto coder Algorithms
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