Our Research Facilities
Clinical Research and Trials Unit (CRTU)
The Clinical Research and Trials Unit (CRTU) is composed of two distinct units, the Clinical Trials Unit (CTU) and the Clinical Research Facility (CRF).
The Clinical Trials Unit
The Norwich CTU provides an opportunity for researchers to work collaboratively with a multi-disciplinary team of clinical, statistical, data management and trial operations experts in order to deliver high quality trials. We have the capability to centrally co-ordinate multi-centre, national and international trials with robust systems to ensure conduct and delivery of trials to the highest quality standards. Further information on the Norwich Clinical Trials Unit .
The Clinical Research Facility
The CRF operates over two sites at the Norfolk & Norwich University Hospitals NHS Foundation Trust (NNUH) and at the University of East Anglia (UEA) campus. The NNUH site comprises six clinical spaces in a ward with associated office space and laboratory facilities and the UEA site comprises eight clinical examination rooms, a DXA scanner, laboratory facilities, a pharmacy holding room and office space.
The role of the CRF is to facilitate research in a safe and efficient working environment and in compliance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP); Research Governance Framework for Health and Social Care (DoH), Medicines for Human Use (Clinical Trials) Regulations 2004, Human Tissue Act 2004 and NNUH UEA joint Standard Operation Procedures (SOPs).
Currently the CRF hosts a variety of project teams working on specific research studies and trials. For further information relating to current studies, please contact the CRF manager. The CRTU also has a core team of research staff who are able to assist project teams with study management, data management and research nurse resources.
Accessing the CRF – who can use it, application process, cost of services
The CRF is managed by an experienced management team. Management approval for the use of specific CRF facilities is made through formal application via the R&D Office and approval is given by the CRF manager. Project teams are invited to discuss their specific requirements with the CRF manager prior to further discussion of the application with the R&D office. The provision of CRF facilities is subject to availability and whilst all efforts are made to ensure the facilities are provided in accordance with the authorised usage, in exceptional circumstances, this may not always be immediately possible.
Clinical space can be provided at both sites, subject to availability. The clinical space comprises:
- UEA site – 8 clinical rooms with a desk, computer, phone, couch and basic clinical equipment
- NNUH site – 6 clinical spaces in a ward and basic clinical equipment
Clinical space is booked in advance through a booking system managed by the CRF administration staff according to the CRF bed and clinical room booking working practice. Staff and researchers who use clinical space are asked to ensure the areas are clean and tidy after use, ready for the next user.
All clinical rooms have basic supplies for blood taking and collecting urine samples. Study specific supplies are usually provided by individual research teams. The CRF is a latex free zone.
The CRF can provide a range of clinical equipment according to the needs of individual research projects. All CRF equipment failures or maintenance problems should be reported immediately to the CRF staff, so that they can take appropriate steps to resolve the issue.
There is very limited space for the storage of non-CRF clinical equipment and this must be approved by the CRF manager. All equipment must meet the electrical standards of the NNUH and the UEA prior to its use on the CRF and, unless equipment is formally accepted as a donation to the NNUH, the Principal Investigator’s department would continue to be responsible for the equipment’s safety, service and maintenance.
Pharmacy Holding Room (UEA site)
Medication provided to study participants at either site is dispensed by the NNUH pharmacy. For study participants attending the UEA site there is a pharmacy holding room located within the CRF where medication can be temporarily stored, but not dispensed, prior to the medication being provided or administered to the study participants, in compliance with Pharmacy Clinical Research SOPs. At all times, the NNUH Pharmacy is responsible for dispensing medication.
The CRF houses a dual-energy X-ray facility (DXA) that provides measurements for research involving body composition (fat and fat-free mass) and bone mineral (content and density) in the whole body and in specific parts of the body (limbs, trunk and other regions of interest). Such assessments may be of relevance to population health or clinical studies; for example, body fat distribution in obesity and bone mineral of the spine and hip for the assessment of osteoporosis.
Whole body DXA scans are usually completed within about seven minutes with the patient or study participant supine and experiencing minimal discomfort, if any. The scan involves use of a very low dose of X-ray radiation, which is equivalent to about one day exposure to normal background radiation in this geographical area. The usual body composition and bone measurements are readily available with other assessments also obtainable using some customised modelling techniques.
The DXA scanner can be booked in advance through a booking system managed by the CRF administration staff. For further information about the scanner please contact Dr Ailsa Welch (firstname.lastname@example.org).
There are two preparation rooms, one located at the NNUH site and one at the UEA site. Each room contains a centrifuge.
Staff and researchers are expected to adhere to the NNUH Trust Infection Control policies and use the protective equipment provided (e.g. plastic aprons, gloves, goggles) where appropriate. Staff and researchers are asked to leave the preparation room in a clean and tidy state after use, ready for the next room user. Staff and researchers are expected to observe the preparation room working practice.
The CRF has two centrifuges. One located at the NNUH site and one at the UEA site.
Only staff and researchers who have received centrifuge training will be permitted to use the centrifuges. Centrifuge training will be provided. Staff and researchers are expected to observe the preparation room working practice.
Fridges and freezers
The CRF has limited samples fridge and freezer capacity at -20°C, -40°C and -80°C. Currently fridge and freezer availability is as follows:
- CRF NNUH site: fridge and -40°C and -80°C freezers
- CRF UEA site: fridge and -20°C, -40°C and -80°C freezers
Samples stored in the fridges and freezers are logged by the respective user and should not be removed by other users without their written permission.
The fridge and freezer temperatures are monitored electronically every 15 minutes and temperature readings are taken from the temperature transmitter website on a daily basis (Monday to Friday). A visual check of the fridges and freezers is carried out on a daily basis (Monday to Friday). If out of range conditions are detected during working hours (9am to 5pm Monday to Friday) and are persistent, PIs of affected studies will be notified of their need to arrange transfer of samples into suitable temporary storage.
To minimise the effect of sample loss associated with potential storage disruption or failure, it is recommended that samples are stored for short periods only (maximum of 8 weeks).
Users are expected to observe the fridges and freezers working practice.
Study Participants’ dining area
The CRF at the UEA has a registered catering establishment. A study participants’ dining area is available for the provision of breakfast for those who have fasted prior to their visit and for making hot drinks for study participants and accompanying guests.
All users must adhere to strict food hygiene rules at all times when using the kitchen. The CRF uses the safer food, better business for caterers manual.
The CRF at the UEA and NNUH is located over 3 open-plan offices and it is important that all users are mindful of their responsibilities when working in an open plan environment. All staff and researchers are asked to be considerate of others and to comply with the CRF open plan office etiquette.
Permanent’ desks’ can be provided at both sites, subject to availability. ‘Hot desk’ facilities are available, subject to availability, in the CRF at the UEA. There are photocopying, printing and faxing facilities on both sites.
A limited range of stationery supplies is kept on the CRTU at both sites.
Meeting Room facility at UEA site
There is a meeting room which can be booked at the UEA site (interview room 1), subject to availability. The room seats 6-8 people comfortably.
The meeting room is booked in advance through a booking system managed by the CRF administration staff according to the CRF meeting room working practice.
Staff and researchers are asked to leave the meeting room in a clean and tidy state after use, ready for the next room user.
|This unit receives National Institute for Health Research CTU Support Funding. This funding has been awarded to support the unit in developing and supporting NIHR trials.|
Telephone: 01603 597285