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NHS Research Scotland – an overview

NHS Research Scotland – an overview. Alison Walker National Coordinator, NRS Permissions CC. Commercial presentation, July 2011. NHS Research Scotland. Background. Collaboration between the Chief Scientist Office (CSO) and 14 unified NHS Boards in Scotland

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NHS Research Scotland – an overview

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  1. NHS Research Scotland – an overview Alison Walker National Coordinator, NRS Permissions CC Commercial presentation, July 2011

  2. NHS Research Scotland Background • Collaboration between the Chief Scientist Office (CSO) and 14 unified NHS Boards in Scotland • Equivalent functions to NIHR, NHS Trusts and DH R&D • Aim to agree and implement national policy to deliver greater efficiency and effectiveness to the NHS R&D function and the Research Ethics function • Pharma – more efficient service + one point of contact • Pan-Scotland working delivered through NRS regional arrangements under which the less research active NHS Boards are linked to the 4 main Boards eg. Commercial Managers meetings • Funding: CSO and Scottish Enterprise

  3. NRS Health Boards

  4. Regional nodes and hubs NRS Permissions CC Regional working – 4 hubs- Ethics- R&D permissions NRS NE NRS E NRS Functions Grampian- NRS Permissions CC Glasgow -NRS IT lead (SReDA) Lothian - NRS Contractual issues and National training Tayside -NRS Governance Issues NRS W NRS SE NRS W

  5. NRS Permissions CC • Coordinating Centre, based in Aberdeen • Dedicated administrative team • Single point of contact for industry and investigators • Manages streamlined process to obtain R&D permissions formulticentreresearch in the NHS Scotland • Liaises with NHS Board R&D offices to facilitate Board and Management permission • Contact point for rest of UK, even if 1 Scottish site • Link with other UK coordinated systems eg. NIHR CSP Unit for UK-wide projects

  6. NRS Permissions CC – the team • R&D Director (part-time) • Prof Alison MacLeod • National Coordinator • Dr Alison Walker • 2 Senior Administrators • Pamela Shand, Stewart Morgan • 1 Administrator • Abi Ayorinde

  7. ‘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

  8. 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?

  9. Processes • Feasibility in Scotland • Scotland only study (multicentre) • UK-wide study (lead R&D office in Scotland) • UK-wide study (lead R&D office in other UK nation) • submit to Scotland ‘in parallel’ • agreed ‘coordinated’ UK process • UK-wide study (not via eg. CSP process) • [even if only 1 Scottish site] • Amendments • Addition of new sites

  10. Feasibility in Scotland • No formal ‘adoption’ process in Scotland • Feasibility service coordinated by Permissions CC • 2 week turn-around for Scotland-wide Investigator response • Permissions CC provides study information to:- • R&D commercial managers (within agreed Health Boards) • Scottish Clinical Specialty Lead (if applicable) • Scottish Topic-Specific Research Network Managers • Potential investigators approached/supported to participate • Permissions CC actively chases responses and feeds back to • Industry • Alternatively, at least involve the R&D commercial manager

  11. 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

  12. Process: Scotland only study (multicentre) NotificationApplicationCheckReviewR&D Permission Full document set Generic Review Certificate of Compliance (CofC) Applicant notifies Permissions CC Permissions CC sends Document Submission Checklist Applicant sends IRAS R&D application to Permissions CC And IRAS SSI Forms to PIs Permissions CC checks / uploads document set onto SReDA; notifies participating R&D offices; requests outstanding documents Local Management permission letter Local Review(s) SSI Forms Confidentiality Agreements as required 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 generic address (nhsg.NRSPCC@nhs.net) • Minimum for Permissions CC to assign generic reviewer:- • confirmation of Health Boards/sites • protocol + Costing Template • Can submit prior to receiving Ethics/MHRA approval • Employ UK Costing Template (as basis for negotiation) • Scottish modelcontract, draft: • mCTA, mCIA, mCTA-CRO, mCIA-CRO • Company/CI send Site-Specific Information (SSI) Forms to • Scottish Principal Investigators (PIs)

  14. Trial Budget Costing • Company asked to submit UKCRN Budget for trial to NRS Permissions CC • Uploaded to web-based research database, as part of global document set • Generic Reviewer reads it alongside protocol and determines whether ‘per patient fee’ is reasonable for Scotland, and if any activity items missed from budget proposal • Local costs then applied by commercial managers

  15. Contract Negotiation • Company asked to submit draft contract intended for use for trial [ideally amodel contract eg. mCTA] to NRS Permissions CC • Uploaded to web-based research database, as part of global document set • Generic Reviewer reviews/negotiates the final template to be used for Scotland, on behalf of all participating Scottish Health Boards • Any specific locally-required changes may be applied by commercial managers, prior to sign off with Health Board

  16. 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

  17. 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

  18. UK-wide study (not via eg. CSP process) [even if only 1 Scottish site] • We encourage companies to submit R&D application to NRS • Permissions CC also for following scenario:- • Only 1 site in Scotland, UK-wide study, but not applying for R&D permission for English sites through the CSP process…

  19. 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

  20. 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

  21. 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

  22. How is Scotland performing? To date, NRS R&D permission times measured from when Permissions CC confirmed receipt ofNRS full document set, to issue of local Management permission at each participating Health Board R&D office [as ‘Net NHS time’].

  23. Commercial: R&D permission times(May 09 – Dec 10)

  24. Feedback - commercial

  25. What are we doing well? • Excellent communication from PCC contact - very clear on how process • worked and what was required. • Approval granted extremely quickly, checks carried out in parallel with ethics. • Permissions CC team attention to detail, constant contact, I was fully advised • of where we were throughout the process, friendliness, detailed checklist was • provided. • Having 1 contact as opposed to 3. • Communication of status, current outstanding documents. • Communications with R&D personnel. • Whole process was very smooth. No requirement to chase up • documentation. The whole set up process was short, painless and • streamlined!

  26. What would you like to see improved? • Improve link between PCC and CSPU. Would like more coordination • between the two but not if it will slow things down. • Relationship/system compatibility between devolved nations. • Increased communication between Permissions CC & CSP and vice versa. 1 • instance where docs transferred from NRS to CSP but weren't uploaded into • CSP system - caused delays to some English R&D approvals. • R&D process was fine and within the expected timelines. Unfortunately • approval was delayed as the ARSAC application had not been submitted in • good time and the R&D approval was only signed once the ARSAC Certificate • was with R&D. • I would like to see the UKCRN and NRSPCC more integrated. It was a • shame we had our chief investigator in England yet had to resubmit the • documents rather than the CSP system being used.

  27. What is NRS doing now? • Now a firmer focus on “outward function”:- • Maintaining register of Scottish clinicians • Website updates • Business development: approaching companies to present ‘on site’ about NRS, Scottish and UK R&D permissions processes, and NRS performance metrics/feedback • Via NHS/Industry partnership forum, linking with Pharma companies and with ABPI (regular meetings of Pharma representatives, CSO (Government) and the 4 R&D Directors) • Specifically working with commercial Clinical Operations Group (cCOG)

  28. ABPI / CSO / NRS Partnership Workshops • Workshop held July 2010 Edinburgh, involving • operational staff from industry and NHS R&D office • colleagues, ABPI and CSO • Further workshop January 2011 London, areas of focus: • - Engagement • - Trial Start-up • - Optimal recruitment

  29. Workshop Action Groups • 3 action groups set up with members from • Industry / CSO / ABPI / R&D staff • Brief is to improve each of the 3 areas:- • - Engagementof industry with R&D offices, • Permissions CC, Investigators • - Trial set up(from R&D permission to recruitment of • first patient) • - Recruitment

  30. What have we done so far ?

  31. Progress of Workshop Action Groups • Engagement • Regional Commercial Trial Facilitators nearly all in place to support trials • requiring access to patients in both primary and secondary care. • Agreed that R&D offices should be notified of SIVs by companies and attend these • where appropriate. • Best Practice • A list of patient databases in Scotland is being collected by the Informatics Centre in • Dundee for potential use by industry for site selection and feasibility. • Recruitment • Key management information data for studies approved from April 2010 being • collected by all Boards. The RAG (Red, Amber Green) mechanism is being introduced • by the NRS Commercial managers to proactively manage and monitor recruitment. • Agreed that Industry should share recruitment data they have collected with R&D • offices on a regular basis.

  32. New Support for Clinical Trials • Commercial Facilitators • - 2 in each node for primary and secondary care. • - Dedicated to assist with feasibility, start up and • recruitment. • - Work under direction of Commercial Managers. • Pool of nurses

  33. 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

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