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Phase I Accreditation Scheme - UK MHRA

The MHRA phase I accreditation scheme is a voluntary scheme for organisations conducting phase I trials, for those conducting first in human (FIH) trials.


The MHRA has provided updated information regarding requirements of the scheme and the associated guidance, along with a new compliance checklist and variation form.

The scheme aims to make sure trials are as safe as possible and to create public confidence in the regulation of phase I clinical trials.


Organisations in the scheme must exceed the basic regulatory good clinical practice (GCP) standards by having additional procedures that include the highest standards for avoiding harm to trial subjects and for handling any medical emergencies.


The guidance on Phase I Accreditation Scheme is in this LINK and about the requirements for Phase I Accreditation scheme in this LINK

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