What will the new system do?
The National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP) is a system for gaining NHS permission from NHS organisations to undertake clinical research, which will fall within the NIHR Clinical Research Network Portfolio.
- reduce the duplication in the NHS review process
- provide a single point to which sponsors and investigators need to apply for NHS permission to start multi-site and single site studies
- ensure clarity regarding the roles and responsibilities of sponsors, investigators, Clinical Research Networks and NHS Trusts.
What are the benefits of NIHR CSP?
NIHR CSP will bring significant benefits. These will include:
- a single national system that fully satisfies all governance and regulatory requirements
- a single point of entry for approvals
- a standardised process by which investigators will gain NHS permission
- reduced bureaucratic burden particularly for multi-site studies
- reduced time to gain approvals which fully satisfy all governance and regulatory requirements
- a high quality process coordinated nationally through the NIHR CSP Unit and locally through Comprehensive Local Research Networks.
How will NIHR CSP work?
NIHR CSP: Builds on best governance practice being used in the NHS R&D management community
- establishes time targets for key stages
- defines and carries out checks that only need to be done once
- minimises the administrative burden placed on researchers
- ensures that researchers obtain all the necessary approvals prior to commencement of their study
- will be accessed by investigators through the Integrated Research Application System (IRAS) to provide a single point of application.
NIHR CSP will be conducted in accordance with national Operating Procedures that clearly define which governance checks are global (undertaken once only per study), which are local (undertaken at every participating site) and who is responsible for carrying them out.
Who is leading the development of NIHR CSP?
The NIHR Clinical Research Network Coordinating Centre is leading on the development of NIHR CSP on behalf of the National Institute for Health Research (NIHR) and in collaboration with key partners such as the UK Clinical Research Collaboration, the National Research Ethics Service, the NHS R&D Forum, the Association of the British Pharmaceutical Industry and researchers.
What are the timescales for implication?
NIHR CSP will be implemented during 2008. It will be initially available to studies that fall within the NIHR Clinical Research Network Portfolio and will be compatible with similar systems being developed in Northern Ireland, Scotland and Wales
How can I find out more?
Further information is available on the UKCRN website
Or you can email the UKCRN
Or you can view the UCKRN powerpoint presentation on CSP
For more information about related developments, such as the Integrated Research Application System (IRAS), visit the UKCRC website.