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EMA Finalizes Key Guideline On Use Of Digital Tech To Capture Electronic Trial Data

 
• By Vibha Sharma

The European Medicines Agency has published a keenly awaited guidance document on how to use computerized systems in clinical trials while ensuring data integrity and patient rights.

Young businessman working on a virtual screen of the future and sees the inscription: Clinical trial
Computerized systems are being increasingly used in clinical research • Source: Shutterstock

The European Medicines Agency has finalized a much-awaited guideline explaining how companies should use computerized systems and collect electronic data in clinical trials in accordance with existing legislation and good clinical practice requirements. 

The provisions of the guideline – prepared by the EMA’s GCP Inspectors’ Working Group (GCP IWG) – will come into...

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