Endoscopy suite

Gene therapy

Video-conferencing

Conference facilities

Dexa scanner

Ultrasound scanner

Research clinics

Laboratories

Wellcome Trust Clinical Research Facility (WTCRF)

Birmingham

Aims of the CRF

•To provide a high quality clinical environment in which patients and healthy participants can undergo research programmes safely in accordance with Good Clinical Practice Guidelines and the Research Governance Framework.

•To translate research into clinical care – we promote a strong collaboration between investigators in Academia and the NHS.

•To promote Clinical Research within the NHS – we contribute to the Induction Programme for all new Consultants appointed at UHBFT.

•To be adaptable - the Facility was designed to be multipurpose and we aim to support all suitable study types across different specialities.

•To be a leader in Research Education – we run training programmes and conferences for clinical and non-clinical researchers.

•To ensure our staff are motivated and valued – we actively encourage staff personal development and ensure they are trained in any study-specific techniques.

Accessing the CRF

Eligibility

The CRF is open to researchers from all professional clinical disciplines across UHBFT, the University of Birmingham and the West Midlands. If you wish to conduct a study in the Facility, contact can be made with CRF staff at any time during the research planning process. Early contact is advisable to discuss the feasibility of a study. The Facility has a statistician who can advise on statistics and study design.

How to apply

In the first instance, all applications made to the CRF are assessed by the Programme Director and the Clinical Manager for feasibility. If there are any concerns regarding the practicalities of conducting the research in the CRF they will be raised at this time.

An application to use the Facility, has to be approved by the Scientific Advisory Committee. This application can be made at the same time as submission to the appropriate research ethics committee. Guidelines and application forms can be obtained from the CRF website, at www.crf.bham.ac.uk, by e-mailing wtcrf@uhb.nhs.uk or contacting the Operational Business Manager on 0121 627 2034.

The role of the Scientific Advisory Committee (SAC)

The CRF Scientific Advisory Committee meets bi-monthly and is chaired by the Programme Director. It comprises senior members of staff from the University of Birmingham, UHBFT, Principal Investigators, a statistician and members of the Facility (ie Programme Director and Clinical Manager, who are non-voting members).

The purpose of the SAC is to review all applications for scientific quality and to prioritise studies when resources of the CRF are limited. Where appropriate, the SAC will provide feedback and offer advice to applicants to resolve any identified concerns.

Once a protocol has been approved for implementation in the CRF, an induction and information pack will be provided to the applicant; these include Guidelines for the use of the Facility.

Funding for Projects

The majority of the Facility’s core funding is provided through the R&D allocation made to the Trust by the NHS and is subject to the appropriate NHS regulations. However, this allocation does not cover the full cost of running the CRF and other sources of funding include University grants, some commercial income and some limited funding related to clinical service provision.

The costs of a research project should be identified and allowance made for all NHS, University and other charges when the project application is being submitted. Advice can be obtained from the CRF, UHBFT R&D Office and the University Finance Department.

The costs will need to include nursing and administrative staff time, cover basic consumables and facilities charges. At the present time, for non-commercial studies, it is not

Introduction

The Wellcome Trust Clinical Research Facility (WTCRF) at the Queen Elizabeth Hospital Birmingham, was established in 2001 and officially opened in 2002 using a Wellcome Trust Millennial Grant for Clinical Research Facilities. The Wellcome Trust, Britain’s largest biomedical charity, launched its £18 million initiative in order to strengthen clinical research in the National Health Service.

This purpose-built dedicated Clinical Research Facility is situated on the first floor of the Wellcome Building (Blue Zone) at the Queen Elizabeth Hospital and will have a direct corridor link to the New Hospital. It is also in close proximity to the University of Birmingham’s Institute of Biomedical Research, reinforcing the collaboration between the University Hospital Birmingham NHS Foundation Trust (UHBFT) and the University of Birmingham Medical School.

Under the leadership of the Programme Director and Clinical Manager, a team of trained personnel work with Principal Investigators from both the Trust and the University to develop, implement and evaluate research protocols. Researchers using the Facility are supported by nursing, administrative and laboratory services, and have access to the full range of clinical and non-clinical services provided by the Trust.

clear how infra-structure costs will be reimbursed through the NHS and other funding bodies. Provision of services over and above those considered routine should be addressed at the time of application. More expensive supplies cannot be provided by the CRF and researchers would have to ensure that these are provided from a research grant, are commercially funded or can be recharged to their Clinical / University Department.

Studies are costed according to whether they are sponsored by a Commercial company or by an Academic or Charitable Organisation, the aim being to support Academic or unfunded research as much as possible within the constraints of the budget. Specific arrangements will vary from project to project and must be agreed in advance with the CRF Clinical Manager before use of the Facility can be agreed.

Commercially Funded Research

In order to safeguard its status as a charity, the Wellcome Trust needs to ensure that activities in which it has made a substantial financial contribution are not used to promote the interests of commercial companies. This principle applies to research undertaken in the Facility and although Industry initiated research may be carried out in the CRF, there are restrictions on the number of projects that can be undertaken. There are, however, instances where commercial enterprises will provide financial support for research that is not initiated by them and not of immediate commercial benefit, so-called investigator initiated research. This type of research may be undertaken in the CRF. Limitations of service

Whilst we will do our best to accommodate studies from all disciplines, there are some facilities we do not have. For example, we are not equipped to carry out research on patients requiring respiratory ventilation, psychiatric patients or children under the age of sixteen. A Paediatric Clinical Research Facility is currently being developed at Birmingham Children’s Hospital which will link in with the CRF at the Queen Elizabeth Hospital to enable research initiated in childhood to be continued into adulthood.

Resources available

The Facility has out-patient, day-patient and inpatient accommodation as well as a range of specialist investigation rooms. The resources available are detailed below.

•Patient / Relative Reception Area – with seating for up to 30 people, TV and vending machine

•2 consulting rooms with network connections, desk and seating

•2 consulting/examination rooms with desk, seating, examination couch, phlebotomy facilities etc.

•Procedure room with examination trolley

•10 bedded/couch day patient area equipped with infusion devices, monitoring equipment, ECG machine

•6 bedded inpatient area: comprising 2 single rooms with air locks and 2 two-bedded rooms. All rooms equipped to HDU standard. The single rooms have en-suite facilities & can be used for barrier or reverse barrier care

• Imaging & Investigational Suite with Colonoscopy equipment, narrow band image intensifier, interventional cardiology and minor operations environment

•Analytical laboratory with Blood Gas analyser, refrigerated centrifuge, microfuge, fridges and freezers, plate reader, gel electrophoresis equipment, pH meter, balance

•Class II laboratory flow cytometer, 2 biological safety cabinets, CO

2 incubator, Coulter counter, endothelial flow

chamber, water bath

•Cardiac studies suite with Exercise Treadmill, Cardiac Echo machine

•Bone densitometry Fan beam densitometer (DXA scanner)

•Seminar / Conference / Discussion rooms - Seminar room for up to 35 people with network

connection, Video Conferencing and live link to Imaging & Investigational Suite for training purposes.

- Conference Room with seating for up to 15 people- Discussion Room for informal meetings up to 5 people,

also used as a Counselling Room

Personnel The WTCRF staff consists of the following: Managing Directors

There are two Managing Directors, one representing the University of Birmingham Medical School and one representing UHBFT. Programme Director

The Programme Director is accountable for CRF issues to the CRF Managing Directors and has overall responsibility for the Facility, which includes managerial and financial responsibility, together with medical aspects of patient care and ensuring medical cover is appropriate. Clinical Manager

The Clinical Manager has overall day-to-day responsibility for CRF services and staff, including clinical and non-clinical staff, patient safety and for ensuring the safe implementation of all studies. Senior Sister

The Senior Sister manages the Nursing Team, and works closely with Principal Investigators to ensure all studies are set up correctly. There is currently a team of 20 whole time equivalent nurses of different grades working in the Facility. Operational Business Manager

The Operational Business Manager is responsible for the administrative staff and administrative processes within the CRF and daily management of the budget. Laboratory Manager

The Laboratory Manager is responsible for ensuring that the CRF Laboratories are compliant with Good Clinical Laboratory Practice Guidelines and other regulatory guidelines (eg Human Tissue Act). The CRF team is also complemented by a Statistician, Senior Radiographer, Medical Laboratory Assistant and a Cardiac Physiologist.

Opening Hours and Contact Details

The Outpatient and Day Case Facilities are staffed from 08.00 – 18.00 Monday to Thursday, and 08.00 – 16.30 on Fridays excluding Bank Holidays. The inpatient Facility can be staffed 24 hours a day Monday to Friday, excluding Bank Holidays.

Contact Details

Please see our website for an up-to-date list of staff names

WTCRFProgramme Director 0121 697 8427Clinical Manager: 0121 697 8458Senior Sister: 0121 627 2030Laboratory Manager: 0121 697 8427Operational Business Manager: 0121 627 2034Reception: 0121 697 8457Fax: 0121 697 8473E-mail: wtcrf@uhb.nhs.ukWeb-site: www.crf.bham.ac.uk

UHBFT Research & Development DepartmentReception: 0121 697 8311Fax: 0121 697 8310E-mail: R&D@uhb.nhs.ukWeb-site: www.uhb.nhs.uk/ research

This booklet provides basic information regarding the Wellcome Trust Clinical Research Facility at the Queen Elizabeth Hospital Birmingham. If you have any specific questions please contact us.

GD

07_3

6974

Des

ign

ed a

nd

Prin

ted

by

Med

ical

Illu

stra

tio

n at

UH

BFT