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Course Information for Data Management for CRAs and Project Managers


Customised In-house Courses are designed for organisations wishing to train a group of your employees at a location of your choice.

Duration: 1 Day

Overview and Challenges of the Data Management (DM) process

  • Data retrieval    
  • Data Entry
  • Data Cleaning
  • Coding
  • SAE reconciliation
  • Lab data
  • QC
  • Data Transfers


Key DM Documents for Clinical Operations to be aware of:

  • Documents
  • Importance

Tracking and Communication (internal and with CROs)

  • Status reports
    • how often
    • what to check
    • how to use reports
  • Query resolution
    • how to handle common and redundant queries
  • Internal and External Communication
    • what, when, how, common pitfalls
    • Use of clean data transfers

    
Close / Lock Procedure

  • Final data retrieval
  • Final cleaning
  • QC
  • Sign Off procedure – what, when, who
  • Blind review
  • Close and lock

For more information and to request details please click here

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