National Institute for Health Research
Coordinated System for gaining
NHS Permission (NIHR CSP)
A single system for processing and reviewing
applications for NHS permission
The Challenge
Research & Development approval
and set up times
are a big factor affecting
the UK’s competitiveness
in conducting clinical studies.
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
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
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 R&D approval times
Predictability
A single system for processing and reviewing applications
for NHS permission.
Speed
Association for British Pharmaceutical Industry (ABPI)
metrics for 2008 show:
82 day MEDIAN time from R&D 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
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
Ensures that 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
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
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 R&D 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
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
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
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 RM&G managers who
have responsibility to manage the process
NIHR CSP Go-Live
NIHR CSP is on schedule for go-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
Conclusion
CSP will provide national clarity to the process of gaining
NHS permissions
CSP will benefit 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
Visit the website for further information
http://csp.ukcrn.org.uk
Or contact the CSPU team at:
csp@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.uk/
Faculty
NIHR Key Workstrands
Investigators
and Senior
Investigators
Trainees
Associates
Research
Universities
Infrastructure
NHS Trusts
Clinical Research
Networks
Research Projects
and Programmes
Patients
and
Public
Clinical Research
Facilities and
Centres
Research Units
and Schools
Research
Governance
Systems
Research
Information
Systems
Systems