1. NHS Research Scotland -Overview -Feasibility -R&D permissions Dr Alison Walker National Coordinator, NRS Permissions CC Commercial presentation

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

3. NRS – ‘hub & spokes’ NRS PCC – NRS Permissions Coordinating Centre NHS GG&G – NHS Greater Glasgow & Clyde Regional arrangements deliver coordinated systems to facilitate clinical research NRS W NRS SE NRS E NRS N NRS SW NRS PCC Four regional hubs –NRS N (NHS Grampian) NRS Permissions CC –NRS SW (NHS GG&C) IT systems lead (SReDA) –NRS SE (NHS Lothian) Contracts National training –NRS E (NHS Tayside) Governance

4. NRS Permissions CC Dedicated administrative team Coordination – Feasibility – Master CDAs – R&D permissions process for multicentre 1 studies Single point of contact Contact point for rest of UK – link with other coordinated systems:- eg. CSP Unit, NISCHR PCU Streamlined process to obtain R&D permission for multicentre research in Scotland CDAs – Confidential Disclosure Agreements 1 Multicentre = > 1 Health Board/Trust in UK

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

6. Processes managed by NRS Permissions CC Feasibility in Scotland Coordination of R&D permissions process Amendments Addition of new sites

7. Feasibility in Scotland No formal ‘adoption’ process in Scotland Feasibility request/questionnaire/CDA sent to Permissions CC Permissions CC forwards study information to:- R&D commercial managers/facilitators (agreed Health Boards) Scottish Clinical Specialty Lead (if applicable) Scottish Topic-Specific Research Network Managers Investigators approached/supported to participate 2 week deadline for response Permissions CC actively chases / feeds back to Industry Companies are put directly in touch with interested parties to take discussions forward At least involve NHS R&D commercial managers

8. Scotland: therapeutic areas of expertise Cardiovascular Disease  Dermatology Gastrointestinal Disease  Infectious Disease Inflammation/Immunology  Metabolic Disease/Diabetes Neuroscience  Oncology Opthalmology  Mental Health Respiratory Disease  Stroke Tissue Research  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 eg. Diabetes, Mental Health, Dementia, Cancer, Stroke, Medicines for Children, Primary Care

9. When to use NRS Permissions CC More than one Board/Trust within UK –Regardless of adoption in England –Regardless of use of CSP, etc. Only time NRS Permissions CC is not used is for SINGLE SITE IN UK studies

10. ‘Full Document Set’ NRS Permissions CC Generic ReviewLocal Review Certificate of Compliance Local Management Permission Lead Health Board Each Health Board Time 0d 30d R&D Permissions Process Overview

11. NRS R&D Permission Process(es) R&D permissions process in Scotland is simple, but can vary depending on:- single- or multicentre? UK-wide study? lead R&D office?

12. UK-wide study (lead R&D office in Scotland) 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 Permissions CC will confirm when we have a full document set 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

13. R&D application to Permissions CC / SSI Forms to PIs Email documents to nhsg.NRSPCC@nhs.netnhsg.NRSPCC@nhs.net Minimum for Permissions CC to assign generic reviewer:- confirmation of Health Boards/sites protocol + Costing Template + draft contract Can submit prior to receiving Ethics/MHRA approval Employ UK CRN Industry Costing Template Scottish model contract, draft: mCTA, mCIA, mCTA-CRO, mCIA-CRO

14. Budget and Contract Budget –UK CRN Industry costing template PbR MFF Scotland = 1.2; (negotiable for smaller Boards) –Generic review Accuracy; Per patient fee; Additional costs –Local review Board specific requirements Contracts –ABPI mCTA – SCOTLAND 2011 –Generic review Final template for Scotland –Local Board specific requirements UK CRN – UK Clinical Research Network PbR MFF – Payment by Results Market Forces Factor mCTA – model Clinical Trial Agreement

15. Scotland wide set up fees Type of feeCost (inc. PbR MFF) R&D set up fee£840 (As per costing template) Pharmacy set up feeDependent on study type as per costing template Site set up fee£500 Observational £1000 Phase 3/4 £1500 Phase 1/2 or GM ARSAC inc Local Med Phys Expert £500 Archiving fee (per box)£300 PbR MFF = Payment by Results Market Forces Factor GM = Genetically Modified

16. UK-wide study (lead R&D office in other UK nation) Applicant submits R&D application to other UK nation eg. to NIHR CSP Unit via IRAS Lead CLRN collates global documents and carries out global governance checks CSP Unit forwards IRAS R&D Form promptly to Permissions CC, along with global documents available at that time Permissions CC contacts study contact promptly to recommend submitting to Scotland (via Permissions CC) in parallel, as well as remind about Scottish SSI Forms for local Scottish PI(s) Follow process as if lead R&D office is in Scotland [no documents/CofC need be forwarded to other UK nation(s)] Permissions CC waits for global documents and Governance Report from Lead CLRN Mini-generic Review for Scotland Certificate of Compliance Local Review(s) Scottish sites For each Scottish Health Board: Local management permission letter If ‘No’ If ‘Yes’

17. How you can help speed up the process ? Apply for R&D permission prior to receiving REC/MHRA approval Documents you send to a REC, send also to Permissions CC (incl. interim) Use the NRS Document Submission Checklist Send correct versions of necessary documents to NRS Permissions CC electronically Employ Scottish model contracts “as published” Obtain PIs’ support prior to sending out Site-Specific Information (SSI) Forms and let them know that the SSI Form is on it’s way Submit amendments sent to a REC to NRS Permissions CC also, and at the same time Commercial customers should also:- Employ the UK CRN Costing Template Get in touch with NRS Permissions CC early to discuss CDAs Get in touch early on to initiate contract / budget discussions with the Commercial Manager of the lead R&D office

18. Processes for: Amendments, New Sites Amendments Permissions CC coordinates amendments for NRS projects Permissions CC should receive documentation, to upload and notify participating Health Boards / other UK nation New sites Adding new Scottish site to Scottish multicentre study, post R&D permission Adding new Scottish site to single-Scottish-site study, post R&D permission Adding 1st Scottish site to UK study

19. Benefits of using NRS Permissions CC Escalation Project Alert Reports Work Area Alerts NRS teleconferences One source of requests for global documents Submit information only once to Scotland Centralised project coordination and management One source of study- wide project queries Project tracking: adherence to target timelines Efficient addition of new sites Coordination of amendments Single point of entry for multicentre permission applications Improved efficiency – reduced duplication We can put you in touch with the right people No adoption process NRS R&D permissions performance oversight

20. Active project management Circulation of ‘Project Alert Report’ every 2 weeks NRS teleconference every 2 weeks, to discuss projects with key R&D office staff from each Node - chaired by Permissions CC, representation from CSO Permissions CC team chases updates / actions / resolution Escalation procedure SReDA ‘Work Area’ alerts – at 20 and 30 calendar days

21. How is Scotland performing? NRS R&D permission times measured from:- receipt of NRS full document set, to issue of local Management permission at each participating Health Board R&D office [as ‘Net NHS time’].

22. NRS Performance Metrics – commercial

23. Commercial project stats Commercial clients to date - 112 Pharmaceutical / Device companies 44 Clinical Research Organisations No. of projects received to date: 347 65% of studies use only 1 Scottish site Feasibilities conducted via NRS Permissions CC: 138 41 through NRS-PPD alliance 12 through NRS-Quintiles Prime Site alliance 85 direct from Pharma No. of feedback questionnaires received = 66 UnacceptablePoorAcceptableGoodExcellent Availability (NRS PCC personnel)? 32635 Competence (NRS PCC personnel)? 1 42930 Helpfulness/attitude/flexibility? 12141 Overall experience of the process? 162830

24. Ongoing/Future plans Website update –Link with Health Sciences Scotland Improve feasibility –Commercial Facilitators R&D involvement in Site Initiation Visit Pharmacy Working Group Patient databases Capability statements Communication Plan Collection of agreed metrics Actively manage recruitment Pharma/CRO and R&D Collaboration –Recruitment/troubleshooting Agreed Scotland wide set up fees

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

26. NRS Permissions CC 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: http://www.NRSPCC.org

27. Health Science Scotland is uniquely placed to set up collaborations between companies and researchers. Graeme Boyle: Senior Program Manager g.boyle@healthsciencescotland.com www.healthsciencescotland.com -Researchers -Research areas and assets -Our population -Case studies Health Science Scotland