The National Institute for Health Research (NIHR) and the UK Clinical Research Network (UKCRC) have postponed the implementation of a new system for streamlining, centralising and standardising sign-offs of multicentre clinical trials by National Health Service (NHS) R&D departments.

The intention was to start operating the NIHR Coordinated System for gaining NHS Permission (NIHR CSP) this month. However, “consultation with a wide range of collaborators indicates that we cannot yet be sure that all of the components of CSP will have been in place for long enough for all key staff to be fully trained and familiar with them,” said the UKCRN, which is leading the implementation process.

The new system will now come into operation later this year. “A later, more phased approach to implementation will ensure a smoother transition for both the research and research management communities and in the longer term deliver a more robust and effective system,” the UKCRN commented, adding that revised timelines for implementation would be provided as soon as possible.

Best Research for Best Health

The NIHR CSP is part of a broader effort to cut administrative burdens and streamline research management under the UK government’s Best Research for Best Health strategy.

It complements initiatives such as the model Clinical Trial Agreements for pharmaceutical companies and contract research organisations, the Research Passport system for researchers not employed by the health service and, most recently, the Integrated Research Application System (IRAS) for research ethics and other approvals by bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) and the Gene Therapy Advisory Committee (GTAC). The NIHR CSP system will link into IRAS.

In the past, getting clinical trials off the ground in the NHS has been hampered by the need to obtain R&D clearance at individual Trust level, with potential variance on parameters such as trial design, costs and insurance arrangements. There has also been duplication of regulatory scrutiny in the sign-off process, leading to delays in study set-up and missed recruitment targets.

The idea is that the NIHR CSP will act as a clearing house for all clinical trials and other well-designed studies (both commercial and non-commercial) intended for the NIHR Portfolio. It will be delivered by a National Coordination Unit (CSP Unit) based in the Coordinating Centre of the UK Clinical Research Network (UKCRN).

This unit will be supported by teams based within the 25 Comprehensive Local Research Networks that make up the NIHR Comprehensive Clinical Research Network set up under Best Research for Best Health.

Among the key features of the NIHR CSP are a single application point for investigators seeking NHS permission to start multicentre studies; a standardised approach for Comprehensive Local Research Networks to co-ordinate the system and local study set-up; and time targets for securing NHS clearance.

The aim is to make sure clinical studies are approved quickly and consistently while addressing all the necessary quality assurance and statutory research requirements, as well as clarifying the roles and responsibilities of sponsors, investigators, trial networks and NHS Trusts.

A pilot project to test the new system and inform its development was launched in July 2007 and is close to completion. The first phase, which wrapped up in October 2007, involved mapping the approval timelines for 10 existing multicentre studies to identify any limiting steps and analyse the permissions pathway.

Phase II of the pilot project looked at a new study going through the approvals process to see how it might be speeded up. In Phase III, the new system is being used to facilitate clearance for a number of studies, including a commercial trial.

For a multicentre study going through NIHR CSP the process will work as follows:

- The Chief Investigator (CI) enters the trial details in IRAS and electronically submits the R&D application to the CSP Unit.
- The CSP Unit validates the application and identifies a Lead Comprehensive Local Research Network (CLRN) (usually one local to the CI)
- The CSP Unit and the Lead CLRN carry out one-time ‘global’ governance checks (e.g., has a favourable opinion been obtained from the research ethics committee?).
- The Lead CLRN informs the other participating CLRNs that the study will be taking place in their Network. The participating CLRNs can then support the Principal Investigators (PIs) in making the necessary local arrangements and obtaining internal authorisations (e.g., from the Trust Clinical Director).
- Each PI submits their Site-Specific Information (SSI) Form through the NIHR CSP.
- Each participating CLRN undertakes ‘local’ governance checks which, once completed, are collated via the NIHR CSP. Each CLRN also facilitates the contracting process, undertakes Site Specific Assessment and ensures that Honorary Research Contracts are in place, where appropriate.
- Once all the global and local checks are completed for a participating site, a Governance Report is provided to NHS organisations, via the CLRN, so that they can provide NHS permission for the study at their site.
The NIHR CSP will work within the framework of national operating guidelines, setting out which governance checks are global and which are local. Details of the checks will be standardised to ensure consistency of review.