four nations nhs/hsc compatibility programme · 2019-06-05 · uk wide uk wide uk wide uk wide uk...
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Four Nations NHS/HSC Compatibility Programme
UK Local Information Pack
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Four Nations Programme Aims
• Continue to streamline processes
• Maintain compatible systems across the UK
• Support cross border research
• Make it easier to do research across the UK
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UK Wide
UK Wide
UK Wide
UK Wide
UK Wide
Original Scope of the Programme Additional
Local Information
Pack
Multiple Scopes
Amendments E-submission Combined REC and R&D Form
Combined REC and R&D Form: Previously the Applicant had to submit separate forms to both the Research Ethics Committee (REC) and Research and Development (R&D) in the Integrated Research Application System (IRAS). This scope of work has delivered a combined form. Impacted Stakeholders: Coordinating Functions, Sponsor (or delegate), R&D.
E-submission: Submits the application for both REC and R&D review in one submission from IRAS to the HRA Assessment Review Portal (HARP). The single submission makes it easier for applicants and does not rely on email. REC and R&D also both have the same document versions. This was delivered over three tranches. Impacted Stakeholders: Coordinating Functions, Sponsor (or delegate), REC.
UK Local Information Pack: The Organisation Information Document replaces the Site Specific Information (SSI) Form in Northern Ireland and Scotland and Statement of Activities (SoA) in England and Wales. This looks to build on the collaboration between the NHS/HSC and Sponsors where site set up is a facilitative conversation. This will initially be delivered out with IRAS. Impacted Stakeholders: Coordinating Functions, R&D, REC, Sponsor (or delegate), Networks/Specialty Groups.
Amendments: The amendments process is to be overhauled. The HRA have appointed a part time resource to begin the work, timescales still to be finalised. Impacted Stakeholders: Coordinating Functions, R&D, REC, Sponsor (or delegate).
A number of additional UK scopes of work have emerged over the past 18 months including Joined Up Validation, ongoing IRAS developments, Study Wide Review overhaul, Combined Ways of Working (CWoW), Joined Up Outcome, Research Passports etc.
Four Nations Programme Scope
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Session Overview
Post IRAS Form
Submission
Changes to IRAS Form Submission
Organisation Information Document
Local Information
Pack Contents
Starting the study
Concluding the process
Sharing the Local
Information Pack
Localised Organisation Information Document
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Introduction of a UK Local Information Pack
• Implementation outside IRAS on 5 June 2019
• A consistent set of documents for study set up across England, Northern Ireland, Scotland and Wales
• Part of the Local Information Pack is an Organisation Information Document, this replaces:
– Statement of Activities in England and Wales
– Site Specific Information Form in Northern Ireland and Scotland
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Site Specific Information
submission in Northern Ireland
and Scotland
Local Information Pack
Covering template email
Localised Organisation Information Document /
Delegation Log
Statement of Activities in
England and Wales
What makes up the Local Information Pack?
IRAS Form Submission
IRAS Form / Documents as
part of IRAS submission
Local Information Pack Contents
Outline Organisation Information Document
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Stages of completion
IRAS Submission
Localisation Completion
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Commercial studies
Covering email in standard template format
IRAS Form
Protocol
Patient information sheet and consent form
Localised Organisational Information Document (commercial)
Model Clinical Trial Agreement
Industry Costing Template or Tool
Delegation Log (This is required for all interventional studies requiring a principal investigator. The sponsor must indicate if this is being provided at a later date ie SIV)
Other documents to help support study set up (e.g. CRF Information, Pharmacy Manual etc.)
For England and Wales – HRA and HCRW Initial Assessment Letter/or Approval letter
What makes up the Local Information Pack?
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Non-commercial studies
Covering email in standard template format
IRAS Form
Protocol
Patient information sheet and consent form
Localised Organisational Information Document (non-commercial)
IRAS Schedule of Events or SOECAT
Model Non-commercial Agreement, if being used as agreement
Delegation Log (This is required for all interventional studies requiring a principal investigator. The sponsor must indicate if this is being provided at a later date ie SIV)
Other documents to help support study set up (e.g. CRF Information, Pharmacy Manual etc.)
For England and Wales – HRA and HCRW Initial Assessment Letter/or Approval letter
What makes up the Local Information Pack?
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Participant Identification Centres
• PICs do not require a Local Information Pack
• Use of Model PIC agreements as subcontract
– Subcontract between participating NHS/HSC organisation and PIC
– Sets out agreed arrangements
– Includes data processing agreement for GDPR
– Commercial and non-commercial versions available
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Organisation Information Document
• An Organisation Information Document provides information to the participating NHS/HSC organisation(s) to support the set up of research
• There are commercial and non-commercial versions
– For non interventional, non commercial studies can be used as an agreement
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Changes to IRAS Form Submission
• An outline Organisation Information Document is part of the IRAS Form submission
– Document is partially completed by Sponsor at IRAS submission
• IRAS Schedule of Events/Schedule of Events Cost Attribution Template (SoECAT)
– For non-commercial studies
– A change for Northern Ireland and Scotland
– Guidance is available in IRAS help
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Localised Organisation Information Document
• The outline Organisation Information Document is localised for each participating site (Sponsor)
– Again, will only be partially complete at this point
• Delegation Log may be included, or provided later ie at Site Initiation Visit
– Guidance and template is available in IRAS help
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Sharing the Local Information Pack
• For sites in England, Northern Ireland and Wales
– Sponsor emails the Local Information Packs to each participating NHS/HSC organisation
• For sites in Scotland
– Sponsor emails the Localised Organisation Information Documents and Delegation Log (as required) to NRS coordinating function in who make available to participating NHS organisations.
• Complete the appropriate email template
– Multiple templates will be required for cross border studies
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Concluding the process
• Sponsor agrees and finalises the localised Organisation Information Document with PI, local research team, networks/specialty groups AND R&D at the same time
– In England, Northern Ireland and Wales NHS/HSC provides confirmation of capacity and capability using a model agreement or the Localised Organisation Information Document according to study type
– In Scotland NHS provides NHS permission
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Summary of stages of completion IR
AS
Sub
mis
sio
n
• Outline
• Part completed
• * Questions completed
• If sites are undertaking different activities, more than one will be required
Loca
lisat
ion
• Sponsor completes with known information
• Will differ across studies
Agr
eem
ent • Finalise
together
• ^ completed by site
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Starting the study
• England, Northern Ireland and Wales
– Confirmation of capacity and capability means that the organisation will take part and is ready to do so when the sponsor says start. For CTIMPs this will be after Site Initiation Visit etc.
• Scotland
– When the NHS study delivery team is ready to start they do so. For CTIMPs this will be after Site Initiation Visit etc.
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Local Information Pack – England/Wales Sponsor or delegate
(Applicant) Central Booking Service
(CBS) Approval Officer/ Approval Admin
Approval Specialist
Prepare submission as usual in IRAS
Participating NHS Organisation
Change: Outline Organisational Information
Document
CBS book to REC or for study wide review for non-REC
studies
Submit in IRAS
Undertake Initial Assessment
Issue Initial Assessment letter and Initial assessment
information for REC
Change: localised Organisational Information Document and template
Change: Organisational Information Document
Validation
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Local Information Pack – NI Sponsor or delegate
(Applicant) Central Booking Service
(CBS) Research Ethics
Committee (REC) Coordinating Function
Prepare submission as usual in IRAS
Participating HSC Organisation
Change: Outline OID(s) drafted according to
activities
CBS book to REC or for study wide review for non-REC
studies
Submit in IRAS
Change: Import into HARP and validate for REC studies
Change: Validate only for Non-REC studies
Download from HARP and upload to EDGE and follow
existing processes
Change: Produce localised OID(s) and Delegation Log(s)
depending on Site Type(s) and email the LIP to organisations using
template email
Change: Access pack
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Local Information Pack – Scotland Sponsor or delegate
(Applicant) Central Booking Service
(CBS) Research Ethics
Committee (REC) Coordinating Function
Prepare submission as usual in IRAS
Participating NHS Organisation
Change: Outline OID(s) drafted according to
activities, IRAS Schedule of Events/SoECAT required for
non-commercial studies
CBS book to REC or for study wide review for non-REC
studies
Submit in IRAS
Import into HARP and follow existing processes
Validate and confirm full document set
(IRAS checklist to be updated)
Download from HARP and upload to SReDA and follow
existing processes
Change: Produce localised OID(s) and Delegation Log(s)
depending on Site Type(s) and email to NRS PCC using
template email
Change: Upload to SReDA and share OID(s) and
Delegation Log(s) with Sites (R&D and
Network/Specialty Group) using template email
Change: Access via SReDA and share with Research
Team (PI) to finalise alongside the Sponsor
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Summary of stages of completion IR
AS
Sub
mis
sio
n
• Outline
• Part completed
• * Questions completed
• If sites are undertaking different activities, more than one will be required
Loca
lisat
ion
• Sponsor completes with known information
• Will differ across studies
Agr
eem
ent • Finalise
together
• ^ completed by site
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Role of the Sponsor – Summary
• Complete Local Information Pack documentation
• Distribute Local Information Packs to all sites in England, Northern Ireland and Wales
• Send localised Organisation Information Documents to coordinating function in Scotland
• Finalise localised Organisation Information Document in a facilitative manner
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Role of the Coordinating Function – Summary
• Carry out Validation/Initial Assessment
– All nations validate
– England and Wales do an Initial Assessment
• In Scotland the coordinating function receive localised Organisation Information Documents and make available through national IT system
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Role of the participating NHS/HSC Organisation – Summary
• Finalise localised Organisation Information Document in a facilitative manner with sponsor
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Transitional Arrangements
• Studies shared with sites before 5 June use Statement of Activities or Site Specific Information Form
• Studies shared with sites from June use Organisation Information Document
• Guidance available on IRAS help
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Non NHS SSI Form
outcome
• for CTMIPs and
Medical Device
studies
• from 5 June being
replaced by a simple
non-NHS/HSC Site
Assessment Form
• reviewed by REC
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Further Support
• Each country to schedule local support as necessary
• Guidance is available on IRAS help
• Q&A’s are available on the Four Nations Compatibility Programme website
• UK Operational Leads contact information