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:

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/

Patients and

Public

NHS Trusts

Universities

Investigators and Senior

InvestigatorsAssociatesTrainees

Clinical Research Networks

Clinical Research Facilities and

Centres

Research Projects and Programmes

Research Units and Schools

Research Governance

Systems

Research Information

Systems

Faculty

Infrastructure

Systems

Research

NIHR Key Workstrands