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Focus on Regulation

Tag Archives: good clinical practice

EMA provides guidance on the sponsor’s role in validating electronic systems used in clinical trials

The European Medicine Agency (EMA) has updated its Good Clinical Practice (GCP) Guideline[1] to clarify the level of validation/qualification that needs to be performed by a sponsor in a clinical trial setting when using an electronic system previously qualified by a vendor. The updated Guideline, issued in the form of a Q&A document, provides that