Prof John Connell, Head of TAHSC Prof Jill Belch, R&D Director Dr Keith Gillon, Senior R&D Manager

Scottish Academic Health Sciences Collaboration (SAHSC) Scottish Government initiative Four nodes: East, West, South and North Aim to raise international research profile, excellence & competitiveness Focus for clinical academic development Streamlining pathway for high quality research: Industry and Council/Charity funded

TAyside medical Sciences Centre (TASC) Joint development between NHS Tayside and University of Dundee Scope/expectation to include other Boards and institutions. Could include eg NHS Fife St Andrew’s University Abertay NHS Forth Valley Stirling University Scottish Crop Research Unit

NHS Academics Committee Chair: James Ferguson TASC Board UoD: Principal VP Dean, Medicine Head of Planning, CMDN NHS Tayside: CEO COO Finance Director Research strategy of TAHSC Node Research Governance MHRA Inspections National Targets and Opportunities TASC Executive Group Implementation of strategy Operational Management Financial Governance SAHSC National Oversight Board Rapid Response Group Research Governance Research Governance Committee Chair: Margaret Smith University of Dundee Court Clinical Trials Unit Collaboration CRC/Training & Staff Trial Management Data Management (in collaboration with Health Informatics/DEBU) R&D office Governance Approvals Risk Assessment BDM/Commercial Legal IP Finance/Costings CSO Liaison TASC Operational Managers Team Imaging NHS Tayside Board Biorepository/ Tissue Bank Networks/Speciality Groups Quality Assurance Audit Standards Pharmacovigilance IMP Handling Scientific Steering Committee Chair: Allan Struthers

Trial Management Tayside Clinical Trials Unit (TCTU) –Start up (SOPs/Guidelines, Contracts & Agreements, Insurance) –Venue (CRC and other) –Running (Trial Management, Data, Stats) –Close down (notifications, archiving etc) UKCRF Registered CRC

Experience & own infrastructure Information and training. Mentoring and support of trial managers as required. Facilitation and support. Potential funding sources. Advice on design and execution. Network of Trialists. Programming, statistical guidance, randomisation etc Experience & limited infrastructure Full trial management, data management etc No experience & no infrastructure Potential funding sources.

Infomatics/Data Management*** Dundee Epidemiolgy and Biostatistics Unit (DEBU) Health Infomatics Centre (HIC) Tayside Clinical Trials Unit Data processors n=2 Statisticians n=2

TASC Costings Research Governance Training CRC CTU Imaging Tissue management Ethics Sponsorship Funders Industry Charities Councils etc One stop shop Investigators

TASC Offices School of Nursing Level 3, Residency ‘C’ Block Move in middle of April Advice/help for all areas of clinical research We are here!

Research Resource Centre Wireless internet connections Some desk tops for ‘hot desking’ Will evolve: Specialist literature Specialist software + + TASC =

Research ‘Clinics’ from May 2010 Jointly organised TASC, Tayside REC, SHIL Representatives from R&D office, TCTU, DEBU, REC and other groups Advice on regulations, scientific design, data management, approvals, ethical issues, IP Last Wednesday of every month TASC offices, Level 3 Residency Block Combination appointments and ‘drop-in’

Research clinics outwith Ninewells –Dental Hospital –Perth Royal Infirmary –Stracathro One Outreach clinic per month on rotational basis Combination appointments and ‘drop-in’ Outreach Research Clinics

TASC Research Training Programme Training events advertised on website Already established: -GCP training, GLP training, TCTU Seminars with SOP training New courses coming soon -GMP for IMP -IRAS

Principal information source for TASC –Web pages for all TASC functions –Research clinics –Training programmes –SOPs ‘Live’ at 5pm 3 rd March 2010 Evolving –Suggestions for content welcome Website

How TASC Operates: TAyside medical Sciences Centre Collaboration Providing service to clinical researchers and Funding Partners University of DundeeNHS Tayside Data handling & management. Statistical advice Imaging, CVD Diabetes, Cancer Neuroscience Inflammation, Populations etc Statistics/ clinical trial design/methdology*** Trial Management Governance *** Sponsorship HIC/DEBU** Imaging*** Tissue Bank*** *** CSO Scottish Lead/Co-Lead

New Frontiers in Research and Teaching TASC To boldly go