Electronic Medical Records Source of Data in Clinical Investigation

       

                                                         Project Founder: Dr. Andrew Bier                           Project Leader: Luis Magalhaes 

 

 

 

  • PROBLEM STATEMENT
    • There is a knowledge gap in ensuring that the use of EHR data collected and used as electronic source data in clinical investigations meets FDA’s inspection, recordkeeping, and record retention requirements.
  • AIM
    • Ensuring the quality and integrity of EHR data collected and used as electronic source data in clinical investigations.
  • OBJECTIVE
    • Facilitate the use of EHR data in clinical investigations.
  • SOLUTION
    • Promote the interoperability of EHR and EDC systems.

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