How will NIHR CSP work?

The basic process for a multicentre study going through NIHR CSP will be:

1. The Chief Investigator (CI) develops a research proposal, completes some basic information about their study in the Integrated Research Application System (IRAS) and electronically submits the Portfolio Adoption Form (PAF) to NIHR CSP. For non-commercial studies this stage takes place before funding has been secured
   
2. The PAF is viewed by the UKCRN Portfolio team to assess whether the research is potentially eligible for inclusion in the Portfolio
   
3. If eligible or potentially eligible, the PAF is received by the CSP Unit who notify the Lead Comprehensive Local Research Network (CLRN), assigned according to the the Lead R&D Office specified on the PAF, who will support the CI with subsequent stages in the process
   
4. If funding is secured, the CI will supply the funding award letter to the Lead CLRN and can then proceed to complete remaining information in the R&D Form in IRAS and submit it to the CSP Unit
   
5. The CSP Unit validates the R&D Form within 3 working days. On validation, the CI will be sent a standard email informing them of progress
   
6. The CSP Unit and the Lead CLRN carry out the ‘global’ governance review. These are the checks that only need doing once for a study (e.g. whether a favourable opinion been obtained from the research ethics committee). This process avoids the need for unnecessary duplication of checks by each NHS organisation
   
7. The CSP Unit informs CLRNs with member NHS organisations participating in the study 
   
8. The participating CLRNs can then support the Principal Investigators in making the necessary local arrangements
   
9. Each Principal Investigator (PI) submits their Site-Specific Information (SSI) Form through CSP. This information will be received by their local CLRN. There will be no need for PIs to submit any of the study-wide documents already submitted by the CI as these will be available to CLRNs via the CSP Unit.
   
10. If the PI has wrongly identified their local CLRN, the SSI Form will be sent to the CSP Unit who will reassign it to the correct CLRN
    
11. The CLRN will validate the received SSI Form within 2 working days. On validation the PI will be sent a standard email informing them of progress.
    
12. Each participating CLRN undertakes ‘local’ governance reviews (e.g. whether the pharmacy department can undertake the study) which, when complete, are collated via the CSP Unit. In addition, each CLRN facilitates the contracting process and ensures that Honorary Research Contracts are in place, where appropriate
    
13. Once all global and local reviews are completed for each participating site, a quality assurance step is completed. Seven calendar days have been allocated for this process. The CI will be sent a standard email once this has been completed for the first site (known as CSP sign off) 
    
14. A Governance Report , summarising all checks undertaken, is provided to each NHS organisation via their CLRN, with all the relevant information to enable each NHS organisation to provide NHS permission for the study at their site. Twenty one calendar days have been allocated for this process 
    
15. Each NHS organisation gives permission for the study to start at that site.

The governance review undertaken within NIHR CSP will depend on the study type (e.g. clinical trial) and numbers of participating sites. Where a study is conducted at a single site or multiple sites within the same CLRN, the CLRN will perform all of the governance checks.

NIHR CSP will be conducted in accordance with national Operating Guidelines. These guidelines will 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. Details of the checks will be standardised in order to ensure consistency of review.

NIHR CSP will be compatible with similar systems being developed across the UK. For more information visit the UKCRC website

How will NIHR CSP be supported?

1. People
   NIHR CSP will be coordinated by a CSP Unit within the UK Clinical Research Network Coordinating Centre working in collaboration with the 25 CLRNs (including staff based within individual NHS organisations who are members of the CLRN)
   
2. Information Systems
   NIHR CSP will be supported by a new web-based system (CSP ReDA) enabling communication between the CSP Unit and CLRNs. CSP Unit staff and those in CLRNs will be able to access all relevant application documents and data through a document repository.

Performance Management
NIHR CSP embeds time standards for key stages within the process. Performance of the CSP Unit and CLRNs in processing studies will be measured against these time standards and NIHR CSP will be reviewed and improved as appropriate.