EMA Updates GCP Guide On Sponsors’ Responsibilities For Overseeing Contracted Tasks

The European Medicines Agency has outlined the documentation and processes that trial sponsors should have in place to demonstrate oversight for activities that are delegated to service providers via written agreement.

Items to be used in a clinical trial to test a potential vaccine for COVID19 coronavirus.
The conduct of a clinical trial should remain traceable and verifiable • Source: Shutterstock

The European Medicines Agency has updated its good clinical practice (GCP) guideline to explain how clinical trial sponsors can demonstrate oversight for activities that are delegated to third-party vendors by written contract.

It builds on earlier advice issued by the EMA with respect to general considerations on how contracting should be addressed....

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