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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.
  • Instead of being prescriptive about what trials records are essential, E6(R3) outlines criteria to help assess whether a record is essential.
  • The new approach aims to enhance trial quality and efficiency but may lead to discussions and challenges during GCP inspections regarding the adequacy and consistency of documentation practices.
  • A non-exhaustive list of records that are generally considered essential is included in E6(R3) and provides a good steer for companies.

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

E6(R3), which was adopted by the Council for Harmonisation on 6 January and will apply in the EU from 23 July, allows sponsors to use...

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