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EMA Clarifies Sponsor's Role In Validating Electronic Systems Used In Clinical Trials

 
• By Vibha Sharma

The European Medicines Agency has issued guidance in response to a growing number of queries from sponsors on how they should qualify/validate the electronic systems they use in a clinical trial setting when the systems have already been qualified by a vendor. The issue has already resulted in deviations being issued during good clinical practice inspections.

Clinical trial
Sponsors must validate the electronic systems they use in their trials • Source: Shutterstock

The European Medicines Agency has updated its good clinical practice (GCP) guideline to clarify what level of validation/qualification sponsors need to perform when using an electronic system in a clinical trial setting that was previously qualified by a vendor. The guideline also clarifies what documentation a sponsor must prepare to demonstrate the validation/qualification during a GCP inspection.

The updated guideline, issued in the form of a Q&A document, clarifies that it is the sponsor who is...

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