Clinical Research Facility (CRU) at the Royal Liverpool Hospital


 

There is a Clinical Research Facilities based in the Royal Liverpool University Hospital carrying out trials of all phases.

Overview of the Clinical Research Unit (CRU)

The purpose of the CRU is to provide a clinical environment, in which pancreatic inpatients, outpatients, and healthy volunteers  can be safely recruited into sponsored and approved early phase (I/II) and later phase clinical trials, which are governed by Good Clinical Practice (GCP) National/International standards, associated regulations and follow the Department of Health’s Research Governance Framework. 

Under the leadership of the executive and scientific directors of the PBRU, chief investigators (CI) and a team of trained research personal in Research, Development and Innovationdevelop, implement and evaluate research protocols in accord with high scientific merit and regulatory requirements. The researchers are supported by research and development, clinical and non-clinical services offered by RLBUHT.

Facilities within the University of Liverpool, such as the Liverpool Cancer Trials Unit (LCTU), and Liverpool Experimental Drug Discovery Unit (LEDDU); which includes the Good Clinical Laboratory Practice (GCLP) Laboratories and Liverpool Tissue Bio-bank, also provide essential services to the CRF.

The CRU is easily accessible from the ground floor of the hospital and is routinely open during normal working hours, with the capacity to operate over 24 hours and at weekends.  The unit is a purpose-built, self-contained area encompassing ward 2C and located on the second floor of the Royal Liverpool University Hospital, to ensure that patients participating in clinical trials receive ongoing NHS care, from the specialist pancreatic clinical team.

The CRU is run by a Translational Trials Team, Lead Clinicians and a team of Specialist Research Nurses, who provide core medical and nursing care relating to the trial. They are supported by wrap-around care from partnership with the RLBUHT. If ongoing NHS care is required for an inpatient, these patients are transferred to appropriate wards and or a critical care environment, where ongoing care is delivered by a core of clinicians and non-research nurses based in these areas.

The CRU  routinely operates at Level 1, however if required, it is equipped to provide Level 2 care for up to 24 hours, prior to the transfer of patients to a formal critical care environment. A procedure is also in place to alert the cardiac arrest team in the event of a trial participant having a cardiac arrest .

The CRU is linked to the Clinical Trials Preparation Room in Pharmacy, where IMPs are stored and used in accord with trial procedures, regulatory requirements and RLBUHT policies. IMPs are administered to trial participants as defined in clinical trial protocols and RLBUHT policies. Pharmaco vigilance of trial participants is carried as dictated by statutory instrument 1031 and its subsequent amendments. 

Samples collected from clinical trial patients/volunteers may be processed within the CRU, before transfer, or sent directly to the GCLP Laboratories for bio-banking and analysis. Such processing is carried out in accord with the appropriate SOP for a particular clinical trail.

The CRU presents an excellent environment for educating and training Staff and Students in carrying out  clinical trials for translational medical research, due to its strong academic links with the University of Liverpool and RLBUHT. All staff have to be ICH GCP trained in inducted into the CRU. 

Please click here for the link to the Royal's Clinical Research Unit website