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Electronic Records: US FDA Updates Guidelines On Use In Clinical Investigations

 
• By Sue Sutter

Revised draft guidance includes recommendations on preparing for FDA inspections, considerations for real-world data and digital health technologies, and the need for service level agreements between sponsors and IT providers.

Laptop with filing cabinets
FDA is providing new guidance on use of electronic records in clinical trials. • Source: Shutterstock

The latest iteration of a US Food and Drug Administration draft guidance on use of electronic systems and records in clinical investigations includes recommendations on preparing for FDA inspections, considerations for real-world data and digital health technologies, and the need for service level agreements between sponsors and IT providers.

The draft guidance, “Electronic Systems, Electronic Records and Electronic Signatures on Clinical Investigations Questions and Answers,” is intended to align a September 2003 guidance on the scope and application...

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