In April 2008 the MHRA developed a scheme to maximise subject safety and to create additional public confidence in the regulatory oversight of phase I clinical trials. The development of the scheme involved wide consultation with representatives from industry associations, academia, NHS, Department of Health, Ethics Committees, the Faculty of Pharmaceutical Medicine and the UK Resuscitation Council.
The MHRA and associated key stakeholders have recently undertaken a detailed review of the scheme and identified a number of aspects that required revision.
The changes include:
- Single classification
- Expanded to include units that function differently to traditional commercial units (non-commercial)
- Allowing the use of a phase I review committee where the Principal Investigator requesting to use the unit may not meet the scheme requirements
- Expanded to encompass more types of phase I trials run in compliance with the accreditation scheme
- First time in patient trials and patient volunteer trials included
- Expanded to encompass need for
- Quality systems covering all activities undertaken in the unit including the accreditation scheme requirements
- Robust resourcing and training of staff to ensure all protocol aspects are adequately performed
The updated scheme gives assurance that accredited units not only meet, but surpass the basic regulatory Good Clinical Practice aspects by having additional ‘best practice’ procedures that encompassed the highest standards for avoiding harm to trial subjects and for handling medical emergencies should they arise. Thus assuring sponsors, as well as competent authorities and ethics committees that accredited units make significant contributions to enhancing the safety of volunteers.
In order to ensure that the scheme standards are understood an associated guidance document is available to consult in conjunction with the scheme requirements. There is also a new application form available for the updated scheme, however, this is not required to be completed by units already accredited. This will only be applicable to units applying for accreditation post 31 October 2013.
The update to the scheme is implemented from 31 October 2013.
Go to the MHRA GCP Phase I Accreditation Scheme website to see the updated scheme and associated documents.