1. The Research Design Service & PRIMENT Clinical Trials Unit Tatiana Taylor Salisbury Research Co-ordinator Dept. of Primary Care and Population Health

2. Research Design Service Research Design Service (RDS) London provides help to those preparing research proposals for submission to peer-reviewed funding competitions for applied health or social care research. Funded by the National Institute for Health Research Free of charge

3. RDS Services Formulating research questions Build an appropriate research team Involving patients and the public Designing a study Appropriate methodologies Regulatory and ethical issues Advice on writing lay summaries Determining the right funding stream Enabling involvement fund

4. How to access support http://www.rdslondon.co.uk/ RDS London UCL Hub Tatiana Salisbury, research co-ordinator t.salisbury@ucl.ac.uk

5. Patient and Public Involvement Workshop Tuesday, 20 March 2012 10am - 4pm Wellcome Collection, Euston Road Registration: www.rdslondon.co.uk For more information about the day please contact Carol Porteous, RDS London Patient and Public Involvement lead, email carol.porteous@kcl.ac.uk

6. Importance of clinical trials units A CTU is an organisation which provides design, conduct and analysis which meet regulatory and governance requirements UK Clinical Research Collaboration registration CTUs must demonstrate a track record of experience in coordinating multi-centre trials, expert staff to develop studies, robust quality assurance systems and evidence of long term viability of capacity for trials coordination. Essential pre-requisite for submitting RCT applications to NIHR

7. PRIMENT CTU Partnership between the UCL Research Department of Primary Care & Population Health, Mental Health Sciences Unit and the Department of Statistical Science Directors: Irwin Nazareth & Michael King Deputy Director: Greta Rait Remit: Collaborate with researchers to develop and/or evaluate complex interventions in primary care, psychiatric and community settings.

8. PRIMENT members Trialists - David Osborn, Greta Rait, Irwin Nazareth, Kate Walters, Marta Buszewicz, Michael King, Nick Freemantle & Rumana Omar Statisticians - Baptiste Leurent, Gareth Ambler, Gianluca Baio, Irene Petersen, Julie Barber, Laura Horsfall, Louise Marston, Mira Vasanthan, Nick Freemantle, Philip Prah, Richard Morris & Rumana Omar Health Economists – Nick Freemantle & Rachael Hunter Research Co-ordinator – Tatiana Salisbury Research Administrator – Andrew Drage

9. What can PRIMENT offer ? Collaboration begins in the early stages of protocol development and extends through to study closure and dissemination of results. – PRIMENT collaboration is free of charge during protocol development and application for funding. Costs associated with PRIMENT involvement during trial implementation and close-out must be included in the funding application. Core team consists of trialist, statistician and health economist (where appropriate) – Trial design – Trial management – Quality control and quality assurance – Database and data management – Statistical analysis – Health economic analysis

10. Data Management EU/GCP compliant data entry systems Web based data entry Remote data entry at clinical sites Anonymised data entry Central data management & monitoring

11. Standard Operating Procedures (SOPs) Protocol development Trial master files Ethics approval Patient information sheet/consent form Training records Initiation/site set up Monitoring MHRA approval Trials supplies/labelling Pharmacovigilance Internal audit of quality assurance system External audit Randomisation Statistics IT/database issues Data management Trial closure Clinical trial reports Archiving Development of trial specific SOPs

12. Current portfolio Total Value: £27.7 million – UCL: £25.01 million 22 Funded RCTs

13. Chief Investigator (CI) contacts PRIMENT staff CI contacts completes PRIMENT support request online Support request provided Support request sent to CTU Co-ordinator (CTUC) Support request received by CTU administrator CTUC reviews request to ensure required information is provided Support request sent to CTU directors CI asked to provide required information CTUC introduces CI to team & facilitates group meeting to discuss project PRIMENT team meets with CI to discuss project Team members provides estimated % WTE to CTUC CTUC discusses suitability of protocol with directors/deputy director; PRIMENT team named CTUC contacts named PRIMENT staff to confirm collaboration on project CTUC sends costing sheet to directors/deputy director for approval CTUC creates project costing sheet Approved costing sheet sent to finance administrator for entry into FIS pFACT sent to CI and PRIMENT team for approval Agreed pFACT sent to Research Office for approval Approved pFACT sent to division lead (when necessary) CTUC sends final pFACT to CI for inclusion in funding application Process for formal approval of research projects

14. Contact Us Website www.ucl.ac.uk/primentwww.ucl.ac.uk/priment General information: Andrew Drage add@gprf.mrc.ac.uk add@gprf.mrc.ac.uk