Another Helpful Resource: EMA’s Good Clinical Practice Frequently Asked Questions Page

10/08/2020

CP EMA 2.jpg

The European Medicines Agency (EMA) has a Good Clinical Practice (GCP) FAQ site which is updated on an ongoing basis. The EMA offers guidance in the form of questions and answers (Q&As) on GCP as approved by the GCP Inspectors Working Group.

The most recent changes occurred in April 2020 to Q&As 8 and 9 regarding further guidance on the use of computerized systems in response to the recently released guidance titled Notice to sponsors on validation and qualification of computerized systems used in clinical trials.

Q&A 8 focuses on pitfalls to be knowledgeable about concerning contractual agreements with vendors for electronic systems used in clinical trials. This Q&A spotlights frequently discovered deviations found during GCP inspections. These categories are:

  • Status of Contracts

  • Distribution of Delegated Tasks

  • Standards to be Followed

  • Audits and Inspections

  • Serious Breaches

  • Compliance with the Protocol

  • Output

  • Exemptions

These common deficiencies can be avoided by upgraded contracts between sponsors and their vendors for electronic systems.

Q&A 9 explores the question of what level of validation/qualification is needed by sponsors when using an electronic system that has undergone qualification previously by a provider as well as covering which documentation is required to be available during inspections.

The path to validation should be based on a risk assessment that bears in mind the potential of the system to alter the reliability of trial results and protection of human subjects as well as its expected use. The assessment of risk should be documented, and sponsor supported. The vendor may supply qualification documentation to the sponsor, but more qualification and/or validation actions may be necessary based on risk.  

As the sponsor is ultimately responsible for the validation and qualification of all trial-related operations sustained by electronic systems, the sponsor is also responsible for providing sufficient evidence of such to GCP inspectors.

This blog is linked to previous blogs:

  • “A Great Resource: The European Medicines Agency’s FAQ Site.” Read more HERE.

  • “The New EMA Guidance: Quality Management of Electronic Systems.” Read more HERE.

-The Clinical Pathways Team

Enjoy this blog? Please like, comment, and share with your contacts.