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National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP)

National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP). Version 1.2 – July 2008. What is the NIHR Coordinated System for gaining NHS Permission (NIHR CSP) ?.

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National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP)

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  1. National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP) Version 1.2 – July 2008

  2. What is the NIHR Coordinated System for gaining NHS Permission (NIHR CSP) ? • A consistent, standardised process for gaining NHS permission in England which addresses all quality assurance and statutory research requirements • A system run through a national CSP Unit and the Comprehensive Local Research Networks to ensure a coordinated approach with local input • A single point to which sponsors and investigators need to apply for NHS permission to start multi-site and single site studies

  3. NIHR CSP: • Builds on best governance practice being used in the NHS R&D management community • Establishes time targets for key stages • Defines and carries out checks that need only to be done once • Ensures clarity regarding the roles and responsibilities of sponsors, investigators, Research Networks and NHS Trusts • Ensures that researchers obtain all the necessary approvals prior to commencement of their study • Will be accessed by investigators through the Integrated Research Application System (IRAS) to provide a single point of application

  4. How will NIHR CSP be supported? • PeopleNIHR CSP will be coordinated by a national CSP Unit based within the UK Clinical Research Network Coordinating Centre working in collaboration with the 25 CLRNs (including staff based within the individual NHS organisations of the CLRN) • Information SystemsA new web-based system (CSP ReDA) will enable communication between the CSP Unit and CLRNs. CSP Unit staff and staff in CLRNs will be able to access all relevant application documents and data through a document repository

  5. How will NIHR CSP work? • NIHR CSP will be conducted in accordance with national Operating Procedures • These procedures will clearly define which governance checks are global (undertaken once only per study), which are local (undertaken at every participating site) and who is responsible for carrying them out • Details of the checks will be standardised in order to ensure consistency of review • NIHR CSP will be compatible with similar systems being developed in Northern Ireland, Scotland and Wales • Performance of the CSP Unit and CLRNs will be measured against the time standards for key stages which are embedded within the process

  6. Participants in NIHR CSP • CSP Unit (CSPU) Coordinates the receipt of study, informing CLRNs involved. Carry out global governance checks with regards to documentation that do not require specialist RM&G knowledge • Lead CLRN The nominated CLRN to carry out the global governance checks which require specialist RM & G knowledge. This will usually be the CLRN where the Chief Investigator is based. May be occasions when this is not assigned on the basis of CI due to resources • CLRN Performs the local governance checks facilitating engagement with the NHS organisation which is a site within the study. Instrumental in communicating with the NHS organisation to facilitate gaining their permission • NHS Organisations Their function is to grant NHS permission

  7. Study Sites • Single site studies • Multi site studies within a single CLRN (single CLRN study) • Multi site studies

  8. Governance Checks on Studies • Global Checks (once only) : Undertaken by CSPU and Lead CLRN on behalf of all sites (Lead CLRN only if study is single centre or single CLRN) • Local Checks (required at each site) : Undertaken by CLRNs or a Lead CLRN (single centre or single CLRN)

  9. NIHR CSP – The Process • Applicant access to CSP • Study review • Integration of CSPU, Lead CLRN and CLRNs • Gaining NHS permission

  10. IRAS is the starting point for CSP

  11. Progress of a multi centre non-commercial study through CSP (1) CI completes PAF for new study within IRAS Portfolio Team assesses eligibility CSPU assigns Lead CLRN CI submits main R&D form to CSP ReDA CSPU identifies participating CLRNs CSPU, Lead CLRN and CLRNs start governance checks SSI forms submitted to CLRNs All checks complete Continued on next slide

  12. Progress of a multi centre non-commercial study through CSP (2) CSPU Sign-off (first site) CLRN produce Governance Report CLRN seeks NHS permission (first site) CSPU Sign-off for other sites

  13. Progress of a multi centre industry study through CSP (1) Company submits protocol to UKCRN/TCRN for adoption TCRN conduct feasibility Adoption panel assesses eligibility CSPU assigns Lead CLRN Main R&D form submitted to CSP ReDA CSPU identifies participating CLRNs CSPU, Lead CLRN and CLRNs start governance checks SSI forms submitted to CLRNs Continued on next slide

  14. Progress of a multi centre industry study through CSP (2) All checks complete CSPU Sign-off (first site) CLRN produce Governance Report CLRN seeks NHS permission (first site) CSPU Sign-off for other sites

  15. Progress of a single site non-commercial study through CSP (1) CI completes PAF for new study within IRAS Portfolio Team assesses eligibility CSPU assigns study to CLRN CI submits main R&D form to CSP ReDA CLRN starts governance checks SSI forms submitted to CLRN All checks complete Continued on next slide

  16. Progress of a single site non-commercial study through CSP (2) CSPU Sign-off CLRN produce Governance Report CLRN seeks NHS permission (first site)

  17. CSP Submissions within IRAS Portfolio Adoption Form Main R&D form SSI forms Supports Portfolio eligibility assessment Supports global checks by CSPU and Lead CLRN Support local checks by CLRNs

  18. Software support for CSP • CSP ReDA • Adapted off-the-shelf solution • Integrated across CCRN • Designed to support CSP • Up to 700 users

  19. CSP ReDA Linking CSPU and CLRNs Interaction via software NHS Organisations CSPU CLRN

  20. CLRN – Governance Report (1)

  21. CLRN – Governance Report (2)

  22. Gaining NHS Permission • The Governance Report will be used as evidence of the governance checks performed along with the associated documents. This is used to secure NHS permission within 21 days. • The date of NHS permission must be recorded and an electronic copy of the letter will be uploaded and placed in the document repository. This will inform CSPU when sites for a study can start recruitment.

  23. Benefits of NIHR CSP • Minimised administrative burden on researchers as well as commercial and non-commercial sponsors • A coordinated and standardised approach resulting in more rapid NHS permission across sites • Reduced duplication across the NHS • Clear distinction between local and national checks • A performance managed process • Electronic document repository

  24. Implementation Timetable • 8 workstreams • Project governance • Process definition • IS systems • CSP Unit development • CLRN/NHS readiness • Training • Pilot study • Communications • CSP goes live in 2008

  25. Any questions? General queries regarding NIHR CSP should be sent to csp@ukcrn.org.uk

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