National Institute for Health Research

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National Institute for Health Research Coordinated
System for gaining NHS Permission (NIHR CSP)
A single system for processing and reviewing
applications for NHS permission
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The Challenge
Research Development approval and set up times
are a big factor affecting the UKs
competitiveness in conducting clinical studies.
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Who is leading the development of NIHR CSP ?
NIHR Clinical Research Network Coordinating
Centre (CRN CC)
In close collaboration with key stakeholders
including UK Clinical Research
Collaboration National Research Ethics
Service NHS Research Development
Forum Department of Health Industry NIHR Clinical
Research Networks Researchers
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What is the NIHR Coordinated System For gaining
NHS Permission (NIHR CSP)?
A consistent, quality assured and standardised
process for gaining NHS permission to conduct
portfolio research in England
A single application point for NHS permission,
through the Integrated Research Application
System (IRAS), for multi-site and single site
studies
A system managed by a national CSP Unit and the
Comprehensive Local Research Networks, to ensure
a coordinated approach with local input
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Why do we need NIHR CSP? The benefits of the new
system are
Consistency A consistent and comprehensive set of
governance checks
Speed To streamline processes to reduce NHS RD
approval times
Predictability A single system for processing and
reviewing applications for NHS permission.
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Speed
Association for British Pharmaceutical Industry
(ABPI) metrics for 2008 show
82 day MEDIAN time from RD notification to sign
off
187 day MEDIAN time from first submission to
first patient / visit
Slow start up leads to reduced recruitment
periods for globally competitive studies
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Consistency and Predictability
Researchers drowning in bureaucracy (BMJ 2004)
Enormous variability in criteria and processes
among 400 NHS Trusts (170 acute)
Separate, multiple applications required for
multi-centre studies
No overall coordination, no standard timelines
Numerous recording systems, no quality control
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Policy Commitment
We aim to create a health research system in
which the NHS supports outstanding individuals,
working in world-class facilities, conducting
leading-edge research, focused on the needs of
patients and the public (Mission)
To achieve this we will Strengthen and
streamline systems for research management and
governance (Strategic Goal 4)
We will unify and streamline administrative
procedures associated with regulation,
governance, reporting, research administration
and approvals, and ensure that procedures and
decisions are rationalised (1.6)
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Key characteristics
A consistent and comprehensive set of governance
checks
Specific checks only conducted once for
multi-centre studies, with clear distinction
between local and national checks
Standardised, managed, end-to-end business
processes
Single application point through IRAS for all
NHS sites
Single, secure online database and document
repository
Integration with NIHR Portfolio processes, and
other NIHR and UK processes over time
A performance framework to measure and drive
improvement
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Benefits
Single application point through IRAS for all
NHS sites.
A standardised, coordinated approach resulting in
more rapid NHS permission for sites
Single, secure online databases and document
repository
Specific checks are only conducted once for
multi-centre studies, with clear distinction
between local and national checks
Built upon best practice in research governance
already in place within the NHS
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How do I apply to NIHR CSP?
Researchers will access NIHR CSP through the
Integrated Research Application System (IRAS)
A single application point for all NHS permission
NIHR CSP will be available for all studies which
are automatically eligible or adopted into the
NIHR portfolio
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NIHR CSP Support
People Training NIHR CSP is coordinated by a
national NIHR CSP Unit National CSP Unit work in
collaboration with the 25 CLRNs, who employ RD
staff within their local NHS organisations
Information Systems A web-based system (CSP ReDA)
with electronic document repository will
facilitate NIHR CSP processing between the
national CSP Unit and CLRNs
Management NIHR Network Coordinating Centre work
with key partners to ensure effective governance
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NIHR CSP in Practice
NIHR CSP will be conducted in accordance with
national Standard Operating Procedures (SOP)
These procedures will clearly define which
governance checks are global (undertaken once per
study), which are local (undertaken at every
participating site) and who is responsible for
carrying them out
Quality assured process enables predictability
i.e. common approach
NIHR CSP will be compatible with similar systems
being developed in Northern Ireland, Scotland and
Wales
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Testing NIHR CSP
First stage pilot - Complete
Mapped the approval timelines for ten existing
multi-site studies to identify any limiting steps
and look at the critical permissions pathway
Looked at a new study currently going through
approval to identify how to speed the permissions
process up
Used the new system to facilitate permission for
a number of studies
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Testing NIHR CSP
Second stage pilot - Complete
Focused on how studies progress through CSP and
the CSP software (ReDA)
Focused on the CSP Operating Guidelines and the
CSP software (ReDA)
Gained feedback from active researchers on the
NIHR CSP user interface
Gained feedback from CLRN RMG managers who have
responsibility to manage the process
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NIHR CSP Go-Live
NIHR CSP went live on 18 November 2008 and will
be continuously developed
Initially available to studies within the NIHR
Clinical Research Portfolio
Once all checks complete there is a
built in double check called CSP sign
off 7 day target
The timeline from CSP sign off to signed NHS
permission letter is 21 days
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Conclusion
CSP is providing national clarity to the process
of gaining NHS permissions
CSP is benefiting NIHR key stakeholders
CSP is a system step change and will take some
time to function properly
CSP is a major step towards busting bureaucracy
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Visit the website for further information http//c
sp.ukcrn.org.uk
Or contact the CSP Helpdesk (Sally Johnson) at
csp_at_ukcrn.org.uk
For NIHR Portal users visit http//portal.nihr.ac.
uk/sites/ukcrn/CSPint
For non NIHR Portal users visit http//portal.nihr
.ac.uk/Pages/Abouttheportal.aspx
For IRAS visit https//www.myresearchproject.org.u
k/
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Faculty
Investigators and Senior Investigators
Associates
Trainees
Research
Universities
Infrastructure
NHS Trusts
Clinical Research Networks
Research Projects and Programmes
Patients and Public
Clinical Research Facilities and Centres
Research Units and Schools
NIHR Key Workstrands
Research Governance Systems
Research Information Systems
Systems
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