NIHR Coordinated System for gaining NHS Permission NIHR CSP Overview Ian Goodall Assistant Director

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NIHR Coordinated System for gaining NHS
Permission(NIHR CSP)OverviewIan
GoodallAssistant Director (Research Management)
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Scope of Presentation

• To describe
• NIHR CSP and how it will work
• The resources which will support delivery of NIHR
  CSP
• The benefits of NIHR CSP
• Links with IRAS and the Portfolio Database
• How NIHR CSP is being implemented

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What is NIHR CSP?

• A consistent, standardised process for gaining
  NHS permission which addresses all quality
  assurance and statutory research requirements
• A system run through a CSP Unit and the CLRNs to
  ensure a centralised approach with local input.
• A single point to which researchers need to apply
  to gain NHS permission

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Existing NHS approval processes

• Approval processes within individual NHS
  organisations are often excellent but
• NHS organisations have different approval
  processes (including submission requirements and
  study assessment).
• Each NHS organisation undertakes all checks
  leading to unnecessary replication
• There are no nationally agreed standards for the
  time taken to provide approval
• Standards of approval (in terms of compliance
  with applicable regulations) are variable between
  NHS organisations

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Typical existing process for multicentre study
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NIHR CSP Process
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The Need for NIHR CSP

• Salman et al. (Feb 2007, JRSM)
• Research governance impediments to clinical
  trials
• Reviewed performance of 50 R D Departments in
  handling 4 multi-centre trials
• median delay of 44 days from application to NHS
  permission
• Most frequently delays linked to local funding
  negotiations and staff shortages in R D

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The need for NIHR CSP

• PICTF Group
• Average time from notification of study to R D
  Departments to NHS permission was 66 days in 2006
  and 111 days in 2007

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NIHR CSP Includes

• Undertaking governance checks in an efficient
  manner on behalf of all participating NHS
  organisations
• Facilitating contracts required at individual
  sites
• Facilitating honorary research contracts
• Research management within the CLRNs will be
  facilitative and proactive when supporting
  researchers

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Resources to Support NIHR CSP

• CSP Unit in conjunction with the 25 (CLRNs), will
  undertake a one-off CSP process before liaising
  with NHS organisations to gain the final NHS
  approval letter.
• Staff within CSP Unit and CLRNs will work to
  standard, nationally agreed Operating Guidelines
• NIHR CSP supported by software integrating the
  work of the CSP Unit and CLRNs

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How will Research Management be structured to
manage NIHR Portfolio studies?
UKCRN CC including Research Management Unit
CLRN Host organisation core staff (incl. Senior
Network Manager)
Trust y
Trust z
Trust x
Distributed CLRN research management within Trusts
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Which studies will run through NIHR CSP?

• Emphasis currently on studies intended for entry
  to NIHR Portfolio
• Longer term wish to open up benefits of NIHR CSP
  to other studies in order to ensure consistency
  in the way that NHS Permission is granted

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Important Concepts and Developments

• Global vs Local governance checks
• Global - document checking (e.g. ethics letter)
• Global - requiring specialist knowledge (e.g.
  adequate peer review)
• Local (pharmacy support in place)
• Mandatory (e.g. ethics) and desirable (e.g.
  consumer involvement) checks

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IRAS submission
Portfolio eligibility by UKCRN Portfolio Team
Ethics approval
Regulatory approval
Eligible or potentially eligible as indicated by
Portfolio Team, TCRNs or SGs
Approvals granted
Not eligible
Comprehensive Local Research Networks X 25
NIHR CSP unit
C S P
Undertake governance checks and indicate to
Trusts that all governance checks ok
Trusts grant approval
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NIHR CSP Links

• Direct feed from IRAS for Portfolio studies
• Output to UKCRN Portfolio Database
• NHS organisations will be involved as CLRN
  members
• Compatible with systems across UK

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Benefits of NIHR CSP

• Minimised administrative burden on researchers as
  well as commercial and non-commercial sponsors
• Coordinated and standardised approach resulting
  in more rapid NHS permission across sites
• Reduced duplication across the NHS
• Clear distinction between local and global checks
• Performance managed process
• Electronic document repository

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Implementation

• NIHR CSP Pilot Study
• NIHR CSP Software
• NIHR CSP Operating Guidelines

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Progress - Pilot Study

• Modelling effect on existing studies (Oxford
  UCL)
• Checking way in which approvals are given
• CSP of 3 new studies
• - CTIMP, Industry, non-interventional

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Progress Supporting Software

• Integration between CSP Unit and CLRNs
• Linked to other NIHR IS initiatives
• Feed from IRAS
• Export to UKCRN Portfolio

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Progress Operating Guidelines

• Draft
• Consult
• Re-draft
• Consult
• Version 1

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Implementation

• Introduce soon!
• Why a delay?
• CLRN infrastructure still being established
• Finalising testing of software

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Conclusion What will NIHR CSP achieve?

• Reduced bureaucracy for investigators and
  sponsors when gaining NHS permission through
  standardisation of required information and
  process of review
• Greater predictability in the time taken to gain
  NHS permission
• Reduced time taken to start studies across
  participating sites
• Improved governance

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• Questions?
• Ian Goodall
• i.goodall_at_ukcrn.org.uk