Our Background

We are a UKCRC fully registered Clinical Trials Unit based in the heart of Bristol. We are situated within Bristol Royal Infirmary, and many of our trials are based in cardiac surgery and cardiology. Our portfolio also includes studies in ophthalmology, general surgery, bariatric surgery, infection control and cancer. We are a multidisciplinary team led by medical statistician Professor Chris Rogers and health services researcher Professor Barney Reeves. Our team consists of trial co-ordinators, research nurses, statisticians, database managers and administrators, as well as experts in Patient and Public Participation (PPI).

“We are proud to be a fully registered UKCRC Clinical Trials Unit. This is an important indication of the quality of our research since it is only awarded to CTUs that can demonstrate a track record of experience in co-ordinating multi-centre trials, expert staff to develop studies, robust quality assurance systems and evidence of long-term viability of capacity for trials co-ordination.”  

                                                                                                                                                        Professor Chris Rogers (2017)

We are part of the National Institute for Health Research (NIHR) Bristol Biomedical Research Centre (BRC) (Cardiovascular Theme), an exciting joint venture between University Hospitals Bristol NHS Trust and the University of Bristol. The NIHR awarded this funding to us in 2007, 2012 and five-year funding was recently awarded in April 2017. The aim of the BRC is to promote translational research, utilising the wealth of academic laboratory research that takes place and using it to improve patient treatment and health. The current five-year funding for the BRC covers 5 research themes, and 3 cross-cutting themes; Cardiovascular Disease; Surgical Innovation; Mental Health; Nutrition; Perinatal and Reproductive Health; Biostatistics Evidence Synthesis and Informatics; Patient and Public Involvement (PPI); Translational Population Science. 


We are also part of the Bristol Trials Centre within the University of Bristol, along with our sister unit Bristol Randomised Trials Collaboration (BRTC). You can read about the different research that is currently ongoing in the Trials Centre here. 

In addition, we are also part of the Bristol Surgical Trials Centre, with funding from the Royal College of Surgeons of England, that aims to enable surgeons to learn more about how to deal with a range of conditions, assess new surgical techniques and discover surgical breakthroughs. The Surgical Trials Centre designs and delivers studies to evaluate new operations, and answer research questions that are important to patients and the NHS.


What We Do

We have a wide range of expertise in the following areas

  •  Study/trial design
  •  Trial monitoring
  •  Statistics
  •  Randomisation
  •  Pharmacovigilance
  •  QuinteT Recruitment Intervention (QRI) (provided by colleagues in the School of Social and Community Medicine). 
  •  SOP development
  •  CRF design
  •  Regulatory and ethics submissions
  •  Data management
  •  Grant application writing
  •  Information technology (database build, remote data capture etc)
  •  Systematic review
  •  Trial management

We have a wide range of expertise in the fields of study design, study management, statistical analyses and data management, including bespoke database design. If you are interested in collaborating with us on a study involving one or more of these areas, please contact us via Bristol Research Support Partners webpage. On this page you will also find a link to our sister unit in Bristol, the Bristol Randomised Trial Collaboration, CONDUCT II, an MRC Hub for Trials Methodology Research which specialises in complex trials, and the Research Design Service in the South West.

As well as collaborating on research, we provide some stand alone services, for example hosting web based databases for studies which are otherwise conducted independently. 
We have also collaborated with clinical trials units in Nottingham (monitoring) and Leeds (international clinical trials toolkit). 

Some descriptionGeneSYS is our flagship data collection and management tool, developed in-house as a cost effective solution allowing the study team to collect, manage and analyse data recorded from a variety of sources for a clinical study.  We now offer GeneSYS to other Units and Organisations on a hosted basis, please contact us to discuss how we can help you.

Quick feature list

  • Fully customisable form layouts allow any form, for instance Case Report Forms (CRFs) and questionnaires, to be faithfully recreated and represented
  • Clear and concise overviews at each stage display the point in the data collection process a study participant has reached
  • Powerful validation rules can be applied to each form, visually prompting users when an entered data item is invalid
  • Customisable searching allows study participants to be found quickly and easily
  • Capability for multiple centres, allowing you to store data from any number of participating sites
  • Scheduled data exports allow data to be extracted and presented in comma separated (csv) format for processing and analysis
  • A system of managed permissions means individual users only see forms and system features based on the role(s) they are assigned to
  • Themes allow you to change the look of your copy of GeneSYS with a custom logo, colours and styles
  • Integral audit trial


Examples of standalone databases provided to external clients

Study  Full Title  Sponsor 
ARENA ARENA - Effectiveness and cost-effectiveness of outpatient physiotherapy after knee replacement: A randomised controlled trial North Bristol NHS Trust 
Cat-PROM Measuring Visual Disability due to Cataract: Development of a cataract patient-reported outcome measure (Cat-PROM) University Hospitals Bristol NHS Foundation Trust 
IPC-PLUS The efficacy of Indwelling Pleural Catheter placement versus IPC placement PLUS sclerosant (talc) in patients with malignant pleural effusions managed exclusively as out-patients (IPC-PLUS Trial) North Bristol NHS Trust 
MiTS Metformin in Tuberous Sclerosis Complex (MiTS)  University Hospitals Bristol NHS Foundation Trust 
PREDICT-CAT Predicting Self-Reported Benefit, Supporting Decision Making and Calibrating Health Utilities for Cataract Surgery University Hospitals Bristol NHS Foundation Trust
REDUCE A Randomised Controlled Trial Evaluating the Efficacy of Indwelling Pleural Catheters in Persistent Non-Malignant Symptomatic Pleural Effusions North Bristol NHS Trust 

Efficient management of Clinical Trials of Investigational Medicinal Products (CTIMPs) requires systems to track the supply and accountability of study drug throughout the lifecycle of a trial. With NIHR CTU support funding CTEU Bristol has developed an IMP management system, IMP-Track, to fulfil this purpose. IMP-Track is available to Clinical Trials Units (CTUs) and research groups and can be customised to suit a wide range of trial designs.


  • Web-based applicationSome description
  • Set-up is configurable independently by CTU users
  • Accommodates a range of trial designs e.g. 2+ group parallel, factorial and cross-over trials
  • Single and multicentre trials
  • Role and site-restricted permissions
  • Secure server
  • Custom modifications on request

Stock control

  • Ordering stock
  • Logging dispatch of stock orders e.g. from the manufacturing pharmacy
  • Logging receipt of stock orders e.g at site pharmaciesSome description
  • Cancel orders
  • Monitoring stock levels


  • In-built randomisation system
  • API - integrates with external randomisation or other systems (on request)

Drug pack accountability

  • Allocating drug packs to participants, inc. replacements for lost drug packs
  • Recording dispensing of drug packs
  • Participant prescription history
  • Recording drug pack returns
  • Recording drug pack destruction
  • Logging lost drug packs
  • Quarantining drug packs
  • Audit trail

Masked RCTs

  • Masked and unmasked user permissions
  • Unmasking of participant allocationsSome description

Other features

  • Configure automated notifications e.g. of low stock or when drug packs are allocated
  • Cancel or undo actions e.g. cancel drug pack allocation or undo drug pack return if performed in error

CTIMPs utilising the IMP-Track management system are VICIGAP and Prompt2


Click here to view the IMP-Track user manual for CTUs.

Frequently asked questions


If you are interested in using IMP-Track for management of IMP for your trial, please contact us on ctimp-manager@bristol.ac.uk or phone 0117 3423151

IMP-Track V2.0 Clinical Trials and Evaluation Unit University of Bristol, Level 7, Bristol Royal Infirmary, Upper Maudlin Street, Bristol, BS2 8HW Copyright © 2018 University of Bristol 


Why Do We Need Public and Patient Involvement (PPI)?

The work of the CV-BRC is carried out for the benefit of everyone and it is only worth doing if it is going to make a positive difference to people’s lives. To make sure of this we need people members of the public to get involved in helping guide the research that we do. Medical training or specialist knowledge is not needed, just some time to spare and a willingness to share your thoughts and ideas with us. We want to work with the wider public to use their experiences to help steer research.

There are two main ways of getting involved in the work of the CV-BRC

  •          On a specific study
  •          On our Public and Patient Advisory group (PAG) 

If you are interested in finding out more about our PPI work or getting involved, then please register your interest.      

More details can be found on the Patient and Public Involvement Website, and our recruitment leaflet is available here.

You can also follow us on Twitter to see what we are up to @BristolBRC or @BrsTrialsCentre                                                                                            

Patient Advisory Group  

Our PPI advisory group is made up of members of the public who meet on a quarterly basis to discuss the work of the CV-BRC. Some of the tasks the group have been involved in have included;

  •          Helping us to decide what research to look at next
  •          Helping us to ensure that what we look at is important
  •          Contributing to the design of the PPI website and recruitment leaflet
  •          Piloting a survey for researchers in the CV-BRC
  •          Advising on trial design

The PAG meetings are held in an informal and relaxed environment and are organised to fit in with its members' other commitments (taking place on an evening, a weekend or during the working day). If you would like to come along to meet the PAG and learn more about PPI, please register your interest. Everyone who joins our PAG group will have the opportunity to attend learning and development sessions to ensure that they are supported and confident in their PPI role.

Working in Partnership

People in Health West of England (PHWE) 

PHWE is a new initiative promoting innovative and effective public involvement in research and evidence-based service improvement. Working together with PHWE ensures that we involve patients and public in our work in the best way possible and that our public contributors can access the learning and development programmes PHWE offer. The PHWE website gives further information as well as providing a portal for other useful resources.


INVOLVE is funded by the National Institute for Health Research, to support active public involvement in NHS, public health and social care research. Their website provides guidance and other resources for public contributors as well as literature developed for researchers looking to involve PPI in their own work.

For more information about taking part in PPI: 

NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) West

West of England Academic Health Science Network (WEAHSN)

Bristol Health Partners (BHP)

NIHR Cardiovascular Biomedical Research Centre (CV-BRC)

NIHR Clinical Research Network (CRN)

Some description

At the CTEU we contribute to a number of MSc courses, teaching modules on research methodology, as well as to the integrative programme for PhD students researching cardiovascular science.

MSc Translational Cardiovascular Medicine

This MSc aims to develop students’ interest in translational cardiovascular research and medicine, and equip them with an enhanced knowledge, understanding and critical awareness of the current approaches and emerging research in this area.

MSc Perfusion Science

The programme for this MSc addresses both academic and professional requirements: it integrates academic knowledge and understanding with both the needs of the working professional clinical perfusion scientist and the demands of professional registration with the Society of Clinical Perfusion Scientists of Great Britain and Ireland (SCPS).

MSc Reproduction and Development

This innovative distance-learning MSc provides a comprehensive theoretical foundation in the areas of human reproduction and development. The programme is designed to appeal to a wide range of postgraduate students, including scientists, nurses and clinicians. Residential workshops will be held in Bristol, comprising lectures and seminars as well as case-based group work, practical sessions and assessments. Each distance-learning unit comprises online tutorials and lectures, with assessment by essays and online questions.

MSc Transfusion and Transplantation Sciences

This programme offers a fascinating range of subjects, including molecular biology, genetics, biochemistry, microbiology, immunology, tissue engineering, clinical medicine, laboratory management and statistics. 

PhD Integrative Cardiovascular Science Studentship Programme

This programme is training the next generation of cardiovascular research leaders. Students learn how to apply the latest research methodology, techniques and knowledge to help patients and the wider public. They receive inter-disciplinary training from epidemiological, clinical, biological and translational experts across the University and the NHS, addressing important challenges of cardiovascular disease.