Application Form for Clinical Trail Permission by oks97298


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									New developments - permissions within the
      NHS for carrying out research

                   Dr Lesley Hall

                   Research Governance Manager
                   Joint Research Office
                   27 March 2009

       IRAS – what it is and how to use it
       Approval process for research – the new Co-
        ordinated System for gaining NHS Permissions
        (CSP) for NIHR portfolio projects
       Site Specific Assessment (SSA) moving to
        R&D from 1st April 2009

    Integrated Research Application
    System (IRAS)
       Web-based system at
       Designed to capture the information needed to be
        submitted by researchers for the relevant permissions
        and approvals for research in the UK.
       Using filters, the system will ensure that data is
        collected and collated appropriately to the type of
        study, approvals and permissions required.
       Researchers enter information once – one set of
        questions which generates a single dataset which
        cross-populates the application forms for each
        reviewing body
    Applications that can be made
    through IRAS
       Administration of Radioactive Substances Advisory
        Committee (ARSAC)
       Gene Therapy Advisory Committee (GTAC)
       Medicines and Healthcare products Regulatory Agency
        (MHRA) – Medicines and Devices (Version upgrade now
        allows Import/Export EudraCT to IRAS)
       Ministry of Justice (National Offender Management Service)
        - England and Wales
       NHS / HSC research offices (R&D)
       NRES/ NHS / HSC Research Ethics Committees (REC)
       Patient Information Advisory Group (PIAG) – England and
        Wales (to be replaced by National Information Governance
4       Board - NIGB)
    Move from NRES to IRAS

       Old NRES application route will close end of
        March 2009 – will not be able to start a new
        application in NRES
       Transitional arrangements for existing applications
        in progress as applications are NOT transferable
        from NRES to IRAS
       Can lock and submit NRES application until Sept
       Old NRES applications will be kept and archived
        so you will be able to access them BUT
       Would have to manually copy information over to
    Using IRAS

       Log into IRAS – can use existing NRES log-in and
        passport or follow instructions to create a new account
       On the first screen, click to „Create New project‟
       Complete the project filter
       Click on „Navigate‟
       Click on „Integrated Dataset‟ on the left of the screen
       On the Navigate tab click on the right, click on A1 and
        work through the form entering data
       When all questions are completed, click on Navigate
        and check each of the separate application forms. All
        questions should be completed.
    Entry page for IRAS

     Once properly logged on takes you to the ‘My Projects’ page and you
                        need to ‘create a new project’

     The importance of the filter page

        Short list of questions about the project
        Dynamic – subsequent filter questions may
         alter depending on responses
        Generates project dataset questions and
         application forms required for study type
        Answer all the questions carefully and refer to
         question specific guidance as necessary

     Submitting applications

        Each review body has different submission
        Select form on the navigation page and then select the
         submission tab for specific guidance
        To print hard copy for submitting follow instructions on
         „submission tab’ - IRAS cannot be locked and instead
         of a „lock code‟ creates a “submission code” with audit
         trail each time a change is made to the dataset
        Prompts applicant to consider whether other review
         bodies need to be notified of the change
     Other IRAS Features and changes

        Contacts – keep details of collaborators
        Standard CVs
        Electronic authorisation
        New research database application form
        Student applications

16                       17/09/07
   Enables you share contact details
    across all your projects
   Access from menu bar

   Or whenever you see the icon
   Build up an address book:
    –   Yourself
    –   You collaborators
     Electronic authorisations

        New functionality from December 2008 to allow
         electronic authorisation in IRAS as alternative
         to ink signature
        Authorisation operates by secure email
         transfer, with audit trail confirming what has
         been authorised, when and who authorised
        Examples - can be used for R&D/SSI Forms,
         sponsor declaration, academic supervisor,
         radiation experts
Research Databases in IRAS
   New specific application for ethical review of research
   Applications for ethical review of research databases not
    mandatory but are accepted for review on a voluntary basis
   This is just for collecting and holding the data on the
    databases or registries – not research
   Any subsequent „research‟ using the data would need
    separate ethical approval OR
   Generic ethical approval for future projects undertaken (like
    research tissue banks) must be in scope of approval
    conditions issued by the REC.
   Future projects under generic approval still require NHS
    R&D permission, where the research will be taking place in
    or through an NHS organisation.
Student applications
   Below doctoral level, the student should no longer be named as
    the Chief Investigator
   Academic supervisor normally to be named as the CI. Student
    should be named at A3 in IRAS (or as a key collaborator at A66
    in the existing NRES form)
   Supervisor should sign both the CI and the supervisor
    declarations as they relate to different sets of responsibilities in
    relation to the project. CVs for both supervisor and student
    should continue to be provided with the application
   Student completes the application form. Student should be
    treated as the “applicant”. All correspondence should be
    addressed to them and copied to the CI
   For doctoral research, student should continue to be named as
    the CI
     NIHR Co-ordinated System for
     gaining Permissions in the NHS
        NIHR CSP will be available for ALL studies which are eligible and
         adopted into the NIHR portfolio
        Non-commercial studies - award funding in open national competition
         across England, with high quality peer review, and with strategic
        Commercial studies – decided via the industry adoption team
        A single system for processing applications for NHS permissions
        A single application point through the Integrated Research
         Application System (IRAS) for multi-site and single site studies
        Single, secure online databases (CSP ReDA) with an electronic
         document repository
        Ensures that specific checks are only conducted once for multi-centre
         studies, with clear distinction between local and national checks

     NIHR CSP Cont’d
        NIHR CSP is co-ordinated by a national NIHR CSP Unit in London
        In collaboration with the 25 Comprehensive Local Research
         Networks (CLRN) – in this area is Northumberland, Tyne and
         Wear CLRN (NTW CLRN)
        NIHR CSP went „live‟ 18 November 2008 and will be continuously
        Submitting to NIHR CSP through IRAS
         –   First thing you must do to gain access to CSP is to get the
             project adopted by the NIHR portfolio – suggest at bid stage or
             at the latest as soon as funding confirmed
         –   Log onto IRAS at

     Using IRAS for NIHR Portfolio
     Adoption and entry to CSP

        On the first screen, click to „Create New
        Complete the project filter
        Q3a lead R&D office in England – tick yes to
         activate 5a to apply through CSP- for NIHR
         portfolio projects only
        Complete and submit Portfolio Adoption Form
        Submit form directly to Portfolio Adoption Team
25       via IRAS
                        Access to CSP through filter form
                 3a (select England) brings up 5a (‘Yes’ for CSP)

MUST now complete and submit the Portfolio Adoption Form immediately after completing the filter
form before proceeding with completing and submitting other applications.
                Access to the Portfolio Adoption Form (PAF)
     From filter page press ‘NAVIGATE’ – form now in ‘Project Forms’

                 PAF completed – click ‘submission’
     Follow instructions to select CLRN and submit PAF to CSP
                  Adoption unit using ‘SUBMIT’ key

     Then what...
        Portfolio adoption team has 2 working days to
         decide if studies are potentially eligible and send
         CI a response (30 days to give final decision)
        Studies that are adopted will be uploaded to the
         CSP ReDA system awaiting all other documents
         from CI
        NOTE: For projects not adopted applications
         are processed directly through relevant R&D
         departments – must contact R&D immediately

Next step
   When the Portfolio team has reviewed the PAF and it
    has been accepted as potentially eligible or eligible
    then the NHS R&D Form submission button is
    activated - follow instructions to submit form to
    supporting CLRN via CSP
   Add SSI forms for participating sites – the appropriate
    CLRN can be selected from the tab
   All forms have to be submitted to CSP through IRAS to
    be available on the CSP system for processing
   All NHS Organisations involved in the project will be
    notified about the project via the CSP system
     Processing approvals in CSP
        Once all governance checks are complete and verified
         the NHS organisation will sign off through CSP
        This notifies the CLRN and a „7‟ day clock for validation
         by the CLRN is activated
        Once validated by CLRN there is a „21 day clock‟ for
         final Trust R&D letter of approval to be issued
        All other NHS organisations should be able to approve
         using evidence and checks from the CSP system in
         addition to their local specific checks
        Research CANNOT begin in NHS organisations
         without the final letter of approval (in NUTH FT signed
34       by the CEO)
     Movement of Site Specific
     Assessment to R&D
        From 1 April 2009 researchers will no longer need to send SSI
         forms to RECs for Site Specific Assessment (SSA)
        RECs will rely on the checks undertaken by R&D departments –
         SSI forms will be sent to R&D directly as part of the application for
         R&D approval
        The favourable opinion from REC will be conditional upon
         permission at relevant NHS organisations – NHS organisations
         already do this type of assessment as routine for R&D approval
        No need to inform REC about new sites EXCEPT for ctIMPs – still
         submit substantial amendment to MHRA and REC as required for
         Clinical Trials Regulations
        There will no longer be form SF1 to maintain a list of approved
         sites for a study

     Any questions?

     List of acronyms
        ARSAC - Administration of Radioactive Substances Advisory Service
        ctIMP – clinical trial of an Investigational Medicinal Product
        EudraCT - (European Union Drug Regulating Authorities Clinical Trials)
        GAfREC – Governance Arrangements for Research Ethics Committees
        IRAS – Integrated Research Application System
        MHRA – Medicines and Healthcare product Regulatory Authority
        NIGB - National Information Governance Board
        NIHR – National Institute for Health Research
        NPSA – National Patient Safety Agency
        NRES – National Research Ethics Service
        PIAG – Patient Information Advisory Group

37                                 17/09/07
     Useful websites
        Department of Health – Research Governance Framework -
        NRES – for ethics applications and guidance - applications must now be made
         through IRAS
        IRAS Website:
        MHRA for Medical Devices and Medicinal Products
        EudraCT website for registering a ctIMP
        Clinical Trials Toolkit – essential guide to ctIMPs

     Useful websites
        Mental Capacity Act information – Department of Health
        Information about Research Passports
        NIHR Portfolio information:
        NIHR Portfolio information for Commercial projects
        Human Tissue Authority
        REC SOPs for use of Tissue – version 3.4, Sept 2007 at: - Chapter 11 and
         Annex H

     Contact details
      Dr Lesley Hall
      Research Governance Manager
      Joint Research Office
      4th Floor, Leazes Wing
      Royal Victoria Infirmary
      Queen Victoria Road
      Newcastle upon Tyne
      NE1 4LP
      Trust R&D main office: 0191 2825959 or email

      Note: Some material within this presentation was provided
      by Dr Janet Wisely, Director, NRES and used with her
40    permission

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