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E6(R3) Introduces Flexibility And Challenges To Clinical Trial Documentation

 
• By Vibha Sharma

The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.

Items to be used in a clinical trial to test a potential vaccine for COVID19 coronavirus.
E6(R3) promotes careful evaluation of essential clinical trial records (Shutterstock)
Key Takeaways
  • The International Council for Harmonisation’s new good clinical practice (GCP) guideline, E6(R3), offers a proportionate, fit-for-purpose and flexible approach to retaining essential clinical trial records.

The non-prescriptive approach adopted by the newly revised global good clinical practice guidance, E6(R3), has raised concern among industry on...

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