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Background

Good Clinical Practice (GCP) for Laboratories (GCPLab) is a quality standard for the collection, storage and analysis of clinical trial samples which incorporates the legal requirements of Good Clinical Practice (GCP). The GCPLab facility is linked to the Liverpool Clinical Trials Unit (LCTU) and the Liverpool Early Drug Development Unit (LEDDU) as shown in the organogram. The GCPLab Facility aims to produce transparent, reliable, reproducible results whilst also giving traceability, auditability and accountability. The GCPLab-LCTU Facility is developing and building on current systems to ensure GCPLab compliance and excellent standards.

GCP is a legal requirement governing translational research with samples from participants on clinical trials. To police this, GCP laboratory facilities are subject to spot inspections by the MHRA. The MHRA have published a description of the legal requirements for such facilities (July 2009) that is subject to inspection. The legal requirements include proof of fitness for all equipment (e.g. service and maintenance contracts) and audit evidence that management have provided a quality assurance programme.

Experimental Cancer Medicine Centres (ECMCs) were established by Cancer Research UK and the Department of Health (NIHR) with the aim of offering laboratory support to early phase clinical trials directed towards the cure or relief of any form of Cancer. ECMC status was awarded to Liverpool in April 2007. The ECMC worked with the Cancer Research UK Liverpool Cancer Trials Unit (part of the LCTU) which co-ordinates national and international trials. On this basis, a biobanking and biomarker facility was established in the Liverpool ECMC, compliant with the standards of GCP.

A major focus of the Liverpool ECMC (now LEDDU) within its first year was the establishment and equipping of dedicated laboratories for sample collection and analyses from clinical trials to the standard of GCLP. The facilities were further expanded in 2009, now comprising the main GCLP Laboratory, Instrument Room, Molecular Biology Laboratory, Microbiology Laboratory and Biobank Freezer Room. There are three core research technicians and a postdoctoral research fellow appointed. There is also a Quality Assurance Manager to ensure GCPLab compliance. In addition, University of Liverpool staff, working on diverse clinical trials, have been inducted and use the facility.

In the GCPLab Facility all work is carried out using Standard Operating Procedures (SOPs) produced before work can begin. These SOPs are version controlled. GCPLab staff undergo regular training in GCP as it applies to the equipment used in the GCLP facility. The equipment is quality controlled on installation (IQ) and only used for the purpose specified. This requires independent Operational Quality (OQ) certification and Performance Quality (PQ) control. Records of the quality control and maintenance of equipment are stored and can be cross-referenced with laboratory books. Any experiment undertaken in the GCPLabs can be inspected with the confidence that a commitment to use a given protocol was made before the experimental data were obtained and that all of the data were stored including any negative experiments.

GCPLab requirements include constant monitoring of all storage conditions and meticulous longitudinal recording of all environmental changes that might affect each and every sample.

Thus the GCPLab-LCTU facility, not only endeavours to ensure that sample collection, storage, analyses and reporting comply with the law, but is in itself a centre of excellence for quality assured research.

The Liverpool Early Drug Development Unit (LEDDU) was set up in 2012 and regularly undertakes phase I and phase I/II trials under the Director Professor Dan Palmer.