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NHS Research Scotland Overview Feasibility R&D permissions

NHS Research Scotland Overview Feasibility R&D permissions. Dr Alison Walker National Coordinator, NRS Permissions CC. Commercial presentation. NHS Research Scotland (NRS). Collaboration CSO 14 NHS Boards in Scotland Funding CSO and Scottish Enterprise Function

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NHS Research Scotland Overview Feasibility R&D permissions

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  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 • ‘..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 CSO – Chief Scientist office

  3. NRS – ‘hub & spokes’ NRS PCC NRS N NRS E NRS SW NRS SE NRS W • 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 • Regional arrangements deliver coordinated systems to facilitate clinical research NRS PCC – NRS Permissions Coordinating Centre NHS GG&G – NHS Greater Glasgow & Clyde

  4. NRS Permissions CC • Dedicated administrative team • Coordination • Feasibility • Master CDAs • R&D permissions process for multicentre1 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 1 Multicentre = > 1 Health Board/Trust in UK CDAs – Confidential Disclosure Agreements

  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 • Morethan 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 Each Health Board Lead Health Board Generic Review Local Review Certificate of Compliance Local Management Permission R&D Permissions Process Overview 0d Time 30d

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

  13. R&D application to Permissions CC / SSI Forms to PIs • Email documents to nhsg.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 modelcontract, 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 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 CSP Unit forwards IRAS R&D Form promptly to Permissions CC, along with global documents available at that time Lead CLRN collates global documents and carries out global governance checks 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) If ‘No’ If ‘Yes’ Permissions CC waits for global documents and Governance Report from Lead CLRN Follow process as if lead R&D office is in Scotland [no documents/CofC need be forwarded to other UK nation(s)] Mini-generic Review for Scotland Local Review(s) Scottish sites Certificate of Compliance For each Scottish Health Board: Local management permission letter

  17. How you can help speed up the process ? • Apply for R&D permissionprior toreceiving REC/MHRA approval • Documents you send to a REC, sendalso toPermissions CC (incl. interim) • Use the NRSDocument Submission Checklist • Send correct versions of necessary documents to NRS Permissions CCelectronically • Employ Scottishmodel contracts“as published” • Obtain PIs’ support prior to sending outSite-Specific Information (SSI)Forms and let them know that the SSI Form is on it’s way • Submitamendmentssent to a RECto NRS Permissions CC also, andat the same time • Commercial customersshould 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. Submit information only once to Scotland Single point of entry for multicentre permission applications One source of requests for global documents No adoption process One source of study-wide project queries We can put you in touch with the right people Centralised project coordination and management Benefits of using NRS Permissions CC NRS R&D permissions performance oversight Efficient addition of new sites Escalation NRS teleconferences Coordination of amendments Project tracking: adherence to target timelines Project Alert Reports Improved efficiency – reduced duplication Work Area Alerts

  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 teamchases updates / actions / resolution • Escalationprocedure • SReDA ‘Work Area’ alerts – at 20 and 30 calendar days

  21. How is Scotland performing? NRS R&D permission times measured from:- receipt ofNRS 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

  24. 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 Ongoing/Future plans

  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 • 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

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