Download - National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP)
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 CollaborationNational Research Ethics ServiceNHS Research & Development ForumDepartment of HealthIndustryNIHR Clinical Research NetworksResearchers
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
The timeline from CSP sign off to signed NHS permission letter is 21 days
Once all checks complete there is a built in double check called CSP sign off – 7 day target
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:
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/
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