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NHS Research Scotland - Overview

NHS Research Scotland - Overview. Dr Alison Walker National Coordinator, NRS Permissions CC (alisonwalker1@nhs.net). Agenda. Background to NRS / NRS Permissions CC Feasibility service NHS R&D permissions process for Scotland NRS Metrics Progress/future plans. NHS Research Scotland.

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NHS Research Scotland - Overview

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

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

  3. 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

  4. 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

  5. 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

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

  7. NRS Permissions CC - Services Coordination of study start-up processes Master CDAs Feasibility across Scotland R&D permissions process for multicentre1 studies Coordination of post-approval processes Amendments Addition of new sites 1 ≥ one site in UK CDA – Confidentiality Disclosure Agreements

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

  9. Key Therapy Areas • 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

  10. Coordinated R&D Permissions

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

  12. 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.

  13. 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

  14. UK Wide Study – Lead from 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

  15. R&D Application Submission Email documents tonhsg.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

  16. Scotland’s performance

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

  18. 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

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

  20. 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.”

  21. Progress and moving forward

  22. 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

  23. 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

  24. 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

  25. 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

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