New version of the phase I accreditation scheme to support integration into GCP risk-based inspection
A new version of the scheme has been issued to support its integration into the good clinical practice risk-based inspection programme.
A new version of the voluntary phase I accreditation scheme and supporting guidance been released.
The update allows the integration of the accreditation scheme into the good clinical practice (GCP) risk-based inspection programme. Phase I accreditation certificates will now be valid for 3 years instead of just 2, unless there are significant GCP or accreditation issues.
Units that have recently undergone their re-accreditation (units that were re-accredited after 28 April 2015) will be issued with a variation confirming the revised expiry period.
Other changes designed to provide additional clarity have also been made to the scheme and associated guidance during this review. These changes cover:
- emergency scenarios, which are are in addition to those undertaken for life support certification
- a diploma in pharmaceutical medicine, which also requires experience in undertaking first-in-human trials
- life support training, which includes paediatric life support training where this is applicable for units undertaking paediatric trials
- documentation regarding provision of emergency equipment and medication
See the new phase I accreditation scheme and supporting document in the guidance for more information.