The Barts Cardiovascular Clinical Trials Unit is in the process of being set up. The Unit will be NIHR compliant and will support the development of research within the Barts Heart Centre. It will provide trials expertise internal to Barts and will support all areas of the cardiovascular research programme and will form part of the Barts CTU (a UKCRC registered unit).
What type of studies does the CV CTU support?
It supports Clinical Trials of Investigational Medicinal Products (CTIMPs), non-CTIMPs (which include trials of complex interventions) and device studies, whether these are single centre, multi-centre, national or international studies. The aim is to support local investigators to deliver high-quality trials by providing oversight of the main trial activities. The CV CTU is a core resource providing infrastructure support for clinical cardiovascular research within Barts and QMUL.
What constitutes CTU involvement?
If you wish to have the CTU as your official CTU for the study it will oversee the main trial activities including: design, risk assessment, costings, protocol development, obtaining approvals (MHRA, NRES, NHS), regulatory and ethics submissions, statistical design and analysis, study oversight, data management, database development, randomisation and unblinding, patient and public involvement, IMP management and recruitment of study staff.
Is my project a CTIMP?
Check the MHRA algorithm
What should I do if I would like support from the CV CTU?
What is the process for CV CTU interim approval?
This flowchart explains the current process for interim approval of projects and how this works with the Barts Heart Centre Peer Review Process.
The new Barts Cardiovascular Clinical Trials Unit (CV CTU) will be NIHR compliant and will support the development of research within the Barts Heart Centre. It will provide trials expertise internal to Barts and enable us to grow our NIHR and BHF funded clinical research funding. The CTU will support all areas of the CV research programme and allow us to increase our funding across the speciality area.
- Will be a part (branch – there are already 4) of the Barts CTU (a UKCRC registered unit)
- Will bring together the expertise needed to undertake a clinical trial from the William Harvey Clinical Research Centre (21 staff), the Barts Heart Centre (16 staff) and the CV BRU, along with funding for 5 new posts
- This will create an NIHR compliant CV CTU
Will provide expertise and advice in the following areas:
- Trial design, sample size and statistics
- Developing proposals and funding applications
- Project management
- Regulations and governance
- Patient and Public Involvement
- Quality management
- Database development
- Recruitment of patients (and staff)
- Trial oversight and day to day management
The set up of the CV CTU is being overseen by a Working Group constituted as follows:
Interim Chair: Professor Amrita Ahluwalia, WHRI
Project Manager: Dr Vivienne Monk, WHRI Clinical Research Centre Manager
Professor Mark Caulfield, WHRI
Dr Sam Mohiddin, Consultant Cardiologist Barts Heart Centre and Chair of Peer Review Committee
Professor Steffen Petersen, Director of Research Barts Heart Centre
Dr David Collier, Joint Clinical Director WHRI Clinical Research Centre
Benoit Aigret, Head of Barts CTU
Chris Smith, Programme Manager QMUL
Any general enquiries should be made to Vivienne Monk