The UK MHRA has updated its requirements and guidance for Phase I accreditation scheme for clinical trials. It has also provided a new phase I accreditation compliance checklist and variation form.
What is the Phase I accreditation scheme?
It is a voluntary scheme for organisations conducting phase I trials, particularly for those conducting first in human (FIH) trials.
What is the aim of the scheme?
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.
About standards in the scheme
Organisations in the scheme have to 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.
You can download the following here:
- Phase I accreditation scheme requirements
- Guidance on Phase I accreditation scheme
- Phase I accreditation scheme application form, compliance checklist and variation form
Source: MHRA website