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.