1. UKCRC Registration: What it may mean for Exeter? Rod Taylor ECTSN Meeting, 15 th Sept 2014

2. o The aim of this process is to help improve the quality and quantity of available expertise to carry out clinical trials in the UK. o To gain UKCRC Registration, need to demonstrate: o a track record of experience in coordinating multi-centre trials o expert staff to develop studies o robust quality assurance systems o evidence of long term viability of capacity for trials coordination In 2007 the UK Clinical Research Collaboration UKCRC developed a registration process which recognises Clinical Trials Units that have the expertise to centrally coordinate high quality multi-centre clinical trials. UKCRC Registration Process I

3. UKCRC Registration Process II Rounds –March 2007; Spring 2009; March 2012; Spring 2015 Applications from any CTU in UK responsible for design, conduct and analysis of multi-centre RCTs or other well designed studies Individual CTUs and collaborative groups eligible to apply Any disease area/topic

4. Task and Finish Advisory Panel Rod Taylor – (Chair) Acting Unit Director Gill Baker – Unit co-Director Tim Eames Dave Richards Sarah Dean William Henley/Fiona Warren Colin Green/Anne Spencer Charlotte Moger Nick Church Paul Ewings

5. UKCRC Registration Process III Two levels of registration offered: –Full Track record in design, conduct and analysis Presence of core team of expert staff Robust QA systems Long term viability –Provisional Developing expertise but currently falls short of full complement of infrastructure, resource and experience for full registration

6. Current 43 Full 2 Provisional

9. UKCRC Registered Clinical Trials Unit Network 2015 Registration Process Section 2 Staffing Overall staffing, cvs of 2 (1) statisticians,2 (1) trial/project managers, 2 (1) IT person(s) Section 3 Infrastructure – Statement of support from host institution – Details of how you ensure long term continuity Section 4 Quality Assurance – List of Essential SOPs (8 new, deviations and serious breaches, urgent safety measures, sponsorship, system validation, database development, database change management, business continuity and disaster recovery) – How you manage quality assurance, risk assessment and monitoring

10. UKCRC Registered Clinical Trials Unit Network 2015 Registration Process Section 5 Information Systems – How data is collected – Info on database systems and their management Section 6 Statistics Section 7 Extent of availability Section 8 Signatures Section 9 Collaborative Group information

11. UKCRC Registered Clinical Trials Unit Network 2012 - International Review Committee Issues – Data management systems sub optimal Use of MS Access strongly discouraged Need for formally validated systems – Quality management required development Key SOPs missing Quality Assurance required development Audit systems required development Risk assessment required development – Need for local collaboration between Units – Need for clarity on organisational arrangements and staff structures

12. NIHR Clinical Evaluations & Trials Support Funding ►Twenty units funded via two funding rounds ►Three year rolling contracts ►Three funding bands: ►£150, 200, 250k ►All payments to be directly to CTUs ►Up to 80% of funds to be recovered after grants awarded ►Recovery by reduction in subsequent support funding payments ►Research project grants are unaffected

13. What it may mean for Exeter? Recognition and profile Local CTU support & signoff for funding bids Drive future resourcing –University of Exeter core funding of additional posts –NIHR infrastructure funding Join ‘the UK CTU club’