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MANAGEMENT GROUP Ian Roberts (Co-director ), Haleema Shakur (Co-director),

MANAGEMENT GROUP Ian Roberts (Co-director ), Haleema Shakur (Co-director), Diana Elbourne (Leading Statistician) Tim Clayton, Liz Allen (Statistics and Clinical trials) Rosemary Knight (Senior Clinical Trial Manager) Patricia Henley (LSHTM Clinical Trials QA Manager)

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MANAGEMENT GROUP Ian Roberts (Co-director ), Haleema Shakur (Co-director),

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  1. MANAGEMENT GROUP Ian Roberts (Co-director), Haleema Shakur (Co-director), Diana Elbourne(Leading Statistician) Tim Clayton, Liz Allen (Statistics and Clinical trials) Rosemary Knight (Senior Clinical Trial Manager) Patricia Henley (LSHTM Clinical Trials QA Manager) Maria Ramos (Senior Project Administrator) Hakim Miah (Database Developer) Updated 13 May 2013

  2. Background • The UK Clinical Research Collaboration (UKCRC) was established in 2004 with the aim of re-engineering the clinical research environment in the UK. • It brings together the NHS, research funders, industry, regulatory bodies, Royal Colleges, patient groups and academia in a UK-wide environment that facilitates and promotes high quality clinical research for the benefit of patients. • A number of key organisations have an overarching aim to strengthen health research in the UK. • National Institute for Health Research (NIHR) • NIHR Clinical Research Network Coordinating Centre • Office for Strategic Coordination of Health Research (OSCHR) • Research Councils UK

  3. Background The vast majority of UKCRC activities are designed to address and improve UK-wide issues UKCRC Stakeholders include: • Arthritis Research Campaign (ARC) • Association of UK University Hospitals (AUKUH) • Better Regulation Executive (BRE) • British Heart Foundation (BHF) • British Medical Association (BMA) • Council for Science and Technology (CST) • Council of Heads and Deans of Dental Schools (CHDDS) • Economic and Social Research Council (ESRC) • General Medical Council (GMC) • Healthcare Commission • Health Foundation • Human Tissue Authority (HTA) • Medical Schools Council (MSC) • Modernising Medical Careers (MMC) • National Cancer Research Institute (NCRI) • National Cancer Research Networks (NCRN) • National Coordinating Centre for Research Capacity Development (NCCRCD) • NHS R&D Forum • NIHR Clinical Research Network Coordinating Centre (NIHR CRN CC) • UK Research Base Funders Forum • UK Trade and Investment (UKTI) • UK Trial Managers Network (UKTMN) • Universities UK (UUK)

  4. Background In 2007 the UKCRC developed a registration process which recognises Clinical Trials Units that have the expertise to centrally coordinate high quality multi-centre clinical trials. • The aim of this process is to help improve the quality and quantity of available expertise to carry out clinical trials in the UK. • To gain UKCRC Registration, we demonstrated: • a track record of experience in coordinating multi-centre trials • expert staff to develop studies • robust quality assurance systems • evidence of long term viability of capacity for trials coordination • Our accreditation was renewed in 2012.

  5. Robust Quality Assurance Systems • Systems and processes in place: • To ensure that staff work to appropriate guidelines and standards • To meet appropriate regulations and legislation (eg the principles of GCP, the NHS Research Governance Framework, the Data Protection Act, the UK Regulations that implement the EU Directive for Clinical Trials) • For risk assessment to guide appropriate monitoring of the whole study process, centrally and at clinical sites • To archive study data at the end of a study and to retrieve it subsequently • To ensure robust and secure information systems

  6. Commitment • UKCRC Registered Clinical Trials Unit must sign up to the following four principles: • Commitment to working with UK Clinical Research Networks to support clinical research eg contribution to national Clinical Trial Unit committees and working groups • Commitment to providing study information and monthly accrual data to the UKCRN Portfolio Database for UKCRN portfolio studies • Commitment to patient/public involvement in studies • Commitment to conducting all trials in accordance with the principles of Good Clinical Practice

  7. Background • UKCRC CTU registration status is valid for 3 years • A review of all UKCRC Registered CTUs is carried out every 3 years to ensure that CTUs can still demonstrate the required competencies for the registration status • UKCRC registration itself does not provide funding for CTUs • CTUs obtain funding via specific projects • Priming funds only support some key CTU staff costs – recouped by NIHR through funded trials

  8. Funding reimbursement to the NIHR • The LSHTM CTU secured ‘priming’ funding from the NIHR for the next 3 years • This funding does not support core staff or infrastructure • It is to allow the CTU to offer longer contracts to key staff and to increase our research capacity • This priming funding will be recouped starting from year 2 • The amount recouped will be based on funding allocated to the LSHTM CTU on NIHR funded trials over the previous funding year • NIHR will look at all the trials where LSHTM CTU involvement has been indicated, then assess the income flowing to the CTU • Funding will be recouped to a maximum of 50% of project funding received

  9. LSHTM CTU • UKCRC registration does not apply to the whole of LSHTM • It is not mandatory to involve the CTU for all research being conducted at LSHTM • LSHTM staff can also work with other CTUs with relevant expertise in conducting research in their specific specialty • If you are applying for funding for, or collaborating on, research where it is indicated that the LSHTM CTU is involved in your application or project, you will need to contact us well in advance to see if your work can be supported by our CTU • Trials adopted by LSHTM CTU must comply with Good Clinical Practice and the Standard Operating Procedures (SOP) in place for the CTU.

  10. LSHTM CTU – adoption • Trials adopted by the CTU must comply with its robust quality assurance systems • Relevant member(s) of CTU management group to be named on grant application • Process for adoption of trials by LSHTM CTU on website – http://ctu.lshtm.ac.uk/

  11. LSHTM CTU – contact • We advise that you make contact with us as early as possible • In the first instance, please complete the Collaboration Enquiry form and send by email to ctu@Lshtm.ac.uk • The management group will then assess your proposal • For further information see: http://ctu.Lshtm.ac.uk/Services.htm

  12. LSHTM CTU – start here • http://ctu.Lshtm.ac.uk/CollaborationEnquiry.doc

  13. ctu.Lshtm.ac.uk Tel +44(0)20 7299 4684 | Fax +44(0)20 7299 4663 | Email: ctu@Lshtm.ac.uk

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