Our Mission

The UKCRC Registered CTU Network is committed to providing its members with the information, guidance and representation in order to successfully support member activities in high quality, efficient, effective and sustainable clinical trials research in the UK. A work programme has been developed in consultation with the UKCRC Registered CTU Working Group, funders and Registered CTU Directors.

UKCRC Registered CTU Working Group:

Adrian Bloor - The Christie Clinical Trials Unit

Ian Ford - University of Glasgow CTU

Janet Darbyshire

Jonathan Sheffield - NIHR CRN

Julia Brown – University of Leeds CTRU (Director)

Lorraine Smith - University of Edinburgh CTU

Michael Bowdery - Welsh Office of Research and Development

Paula Williamson - University of Liverpool CTRC

Rhiannon Whitaker - North Wales Organisation for Randomised Trials in Health

Sarah Rudkin - Arthritis Research UK (Chair)

Tom Walley - NIHR Evaluations, Trials and Studies (NETS)

Work Programme

A work programme has been developed in consultation with the UKCRC Registered CTU Working Group, funders and Registered CTU Directors. Key work programme activities include:

1. UK Registration Process with review of currently registered Units based on an International Panel Review model and annual review of status.

2. Networking opportunities between UKCRC Registered CTUs enabling:

· common approaches to addressing issues across Registered CTUs resulting in optimisation of resources· facilitation of shared best practice amongst Registered CTUs including mentorship of developing CTUs resulting in increased quality systems and processes across the Registered CTUs

· opportunities for CTUs to contribute to new developments and initiatives within the clinical research community (funders, networks, and regulators)

· greater visibility of Registered CTUs providing easy access to information about their expertise to other stakeholders, particularly funders and clinical investigators· academic/industry partnerships to become more attractive resulting in increases in collaboration

· development of more coordinated approach to the DMCs and TSCs by exploring initiatives such as a directory of expertise and coordinated meetings in specific disease areas. This would optimise the use of the available expertise and reduce costs of the oversight of clinical trials. Networking will include biannual CTU Directors meetings, biannual meetings for CTU Operational staff (Information Systems, statisticians and quality assurance representatives,

n.b. trial managers to meet within the NIHR trial Management Network infrastructure), continuation of existing communication routes – JISC Mail, ‘The Exchange’ Newsletter. In addition a new interactive website will be developed and maintained to facilitate information exchange between CTUs for all disciplines and levels of staff.

3. Creation and support for the following Working Groups:

a. Industry

To explore frameworks for facilitating and publicising collaborations with industry and small to medium enterprise and medical device companies. To share previous experiences of working with industry to achieve greater transparency and consistency into academic-industry collaborations, addressing key issues such as IP and publications policy.

b. Core Infrastructure

A UK-wide review of Registered CTU core infrastructure funding with the aim of mapping the availability of resources and expertise to support design and delivery of clinical trials. Interaction with a range of funders and host institutions to publicise the importance and benefits of core infrastructure funding in the delivery of cost effective high quality clinical trials.

c. Costing Models

Development of a standardised approach to costing studies. The aim of this initiative is to increase transparency, consistency and clarity in funding applications to assist both applicants and funding bodies.

d. Efficient Trial Conduct

Exploring new approaches and systems to improve efficient trial conduct. e. Operational themed meetings -Quality Assurance, Information Systems and Statistics in order to share best practice and to help develop standard approaches to common issues.

4. Representation of CTUs on national/ international groups and in national/international consultations

a. The Registered CTUs will be represented on key strategy and consultation groups (e.g. MHRA GCP Consultative Committee, MHRA/DoH/MRC Risk Assessment Working Group, NETSCC Trials Unit Advisory Group). CTU views on relevant consultations from national or international bodies eg the EU or MHRA will be collated and submitted.

5. Publicity for the UKCRC Registered CTUs

a. A dedicated online resource presenting a branded identity and showcasing the Registered CTUs through an online directory of Registered CTU research interests and contact details.

b. Publicity material for funders, industry, small to medium enterprises, collaborators which showcases the Registered CTUs and highlights the importance of and benefits of engagement with Registered CTUs in terms of cost effective high quality delivery of clinical trials.

6. Focus for interaction with MRC Methodology Hubs Network and NIHR Research Design Services.