2. NHS Research Scotland - Overview Dr Alison Walker National Coordinator, NRS Permissions CC (alisonwalker1@nhs.net)

3. Agenda Background to NRS / NRS Permissions CC Feasibility service NHS R&D permissions process for Scotland NRS Metrics Progress/future plans

4. NHS Research Scotland Collaboration –CSO –14 NHS Boards in Scotland Funding –CSO and Scottish Enterprise Function –coordinate R&D processes and systems ‘..agree and implement national policy to deliver greater efficiency in the NHS R&D and Research Ethics function’ More efficient and effective service for industry CSO – Chief Scientist office

5. Hub & Spoke Model Four regional hubs – NRS North (NHS Grampian) NRS Permissions CC – NRS South West (NHS GG&C) IT systems lead (SReDA) – NRS South East (NHS Lothian) Contracts National training – NRS East (NHS Tayside) Governance Regional arrangements deliver co-ordinated systems to facilitate clinical research GG&C – Greater Glasgow & Clyde

6. NRS Permissions CC Dedicated administrative team Single point of contact Feasibility service Coordinate study set-up Link with other UK-coordinated systems: –CSP Unit (England) –NISCHR PCU (Wales) –Northern Ireland Gateway Streamlined process to obtain R&D permission for multicentre research in Scotland

7. NRS Permissions CC - the team Director – Professor David Reid National Co-ordinator – Dr Alison Walker Senior Administrators – Pamela Shand – Karen Innes Administrator – Lindsay Grant

8. NRS Permissions CC - Services Coordination of study start-up processes –Master CDAs –Feasibility across Scotland –R&D permissions process for multicentre 1 studies Coordination of post-approval processes –Amendments –Addition of new sites CDA – Confidentiality Disclosure Agreements 1 ≥ one site in UK

9. Feasibility in Scotland Protocol/Questionnaire received by NRS Permissions CC Commercial R&D Managers & Facilitators Scottish Topic-specific Network Managers Scottish Clinical Speciality Leads Specialist Investigators Collated feedback to Sponsor Process actively managed with an aim to feedback within 2 weeks

10. Key Therapy Areas Cardiovascular Disease Gastrointestinal Disease Inflammation/Immunology Neuroscience Ophthalmology Respiratory Disease Tissue Research Dermatology Infectious Disease Metabolic Disease/Diabetes Oncology Mental Health Stroke Women’s Health Extensive imaging infrastructure and latest biomedical NMR imaging techniques Scottish Clinical Specialty Lead represented on UKCRN/NIHR Specialty Groups Topic-Specific Research Networks e.g. Diabetes, Mental Health, Dementia, Cancer, Stroke, Medicines for Children, Primary Care

11. Coordinated R&D Permissions

12. Process Overview Processes run in parallel 30 calendar days from ‘full document set’ to R&D permission Initial approach to NRS Permissions CC ‘Full document set’ received by NRS Permissions CC Lead Health BoardLocal Health Board Certificate of Compliance Generic Review Management Approval Local Review

13. When to submit to NRS Permissions CC R&D permission process in Scotland is simple, but can vary depending on:- –single- or multicentre in Scotland? –UK-wide study involving CSP, etc? –lead R&D office? When to submit via NRS Permissions CC –More than one Board/Trust within UK Regardless of adoption in England Regardless of use of CSP, etc.

14. Lead R&D Office in Scotland NRS Permissions CC: –collates the global document set –forwards IRAS R&D Form plus global document set, promptly, to other UK Coordinating Centres –assigns a Lead reviewer in Scotland to carry out a generic review on behalf of the UK –forwards the Certificate of Compliance (CofC) to other UK nations Scottish Boards and UK Trusts/Boards complete local reviews

15. UK Wide Study – Lead from Scotland Permissions CC will confirm when we have a full document set Applicant notifies Permissions CC of UK-wide multicentre project Permissions CC sends applicant ‘Document Submission Checklist’ Applicant sends IRAS R&D application to Permissions CC; and IRAS SSI Forms to PIs (UK-wide) Confidentiality Agreements as required Permissions CC uploads documents to SReDA; notifies participating Scottish R&D office(s); requests outstanding documents; assigns lead reviewer Generic ReviewLocal Review(s) Scottish sites Permissions CC emails IRAS R&D Form to other UK nation(s) Certificate of Compliance (CofC) For each Scottish Health Board: Local management permission letter Permissions CC emails CofC to other UK nation(s) Permissions CC emails global documents to other UK nation(s) SSI Form

16. R&D Application Submission Email documents to nhsg.NRSPCC@nhs.net Confirm participating Health Boards/sites Submit prior to Ethics/MHRA approval IRAS SSI Form sent to local Investigators (PI), for completion, signing and submission to local R&D office For commercially-sponsored projects: UK CRN Industry Costing Template current version Scottish model contract –mCTA, mCIA, mCTA-CRO, mCIA-CRO, mRegistry/Epidemiology

17. Scotland’s performance

18. NRS Performance Metrics Non-commercial studies: R&D permission times (Jan 10 – Dec 12)

19. Commercial Statistics Commercial clients to date: –134 Pharmaceutical / Device companies – 49 Contract Research Organisations Total number of commercial projects : 441 –67% using only a single site in Scotland Feasibilities (commercial) –224 coordinated

20. NRS Performance Metrics Commercial studies: R&D permission times (Jan 10 – Dec 12)

21. Commercial Feedback “Time to approval accurate and simple advice on how to submit; R&D accepted NIHR budget with no questions (a very refreshing change!). Very quick, straightforward and reliable (it’s the submission I don’t have to worry about!). ” “Process was smooth from start to finish. Scottish site was first site to be granted R&D approval, 7 days before second R&D approval at English site.” “R&D communication and approval process. Excellent, in fact, encouraging to Sponsors to perform more studies in Scotland.” No. of replies = 84UnacceptablePoorAcceptableGoodExcellent Availability of NRS PCC personnel? 43444 Competence of NRS PCC personnel? 1 43641 Helpfulness/attitude/ flexibility of NRS PCC? 12654 Overall experience? 163541

22. Progress and moving forward

23. Progress to date Consistent R&D permission times Single commercial price for Scotland Patient Recruitment –Management systems to monitor recruitment –SHARE – patient database Re-branding Website (www.nhsresearchscotland.org.uk) –Board capability statements Engagement with Industry –NHS/Industry partnership forum –Visits and presentations

25. Moving forward Engagement –Industry Liaison Manager Health informatics –Safe havens Website development –Enhanced capability statements –Commonly requested documents Lab certificates CVs ?? Commercial prices Recruitment –Active management

26. Supporting Studies Locally Commercial Facilitators – 2 in each node (primary and secondary care) – Assist with feasibility, start up and recruitment Nurses –Dedicated research nurses –Expert support for investigators Imaging infrastructure –Dedicated scanners and reporting

27. Contact Details Dr Alison Walker National Coordinator NHS Research Scotland Permissions Coordinating Centre (NRS Permissions CC) alisonwalker1@nhs.net Tel: 01224 554051 NRS Permissions CC Office nhsg.NRSPCC@nhs.net Tel: 01224 552690 Website: www.nhsresearchscotland.org.uk/NRSPCC