Setting up your study in the NHS - assessing, arranging and confirming local capacity and capability

Health Research Authority (HRA) Approval is the new process for the NHS in England that brings together the assessment of governance and legal compliance with the independent REC opinion.  It replaces the need for local checks of legal compliance and related matters by each participating organisation in England.

The focus of each participating organisation is to assess, arrange and confirm the practical aspects to ensure they have the capacity and capability to participate in the study and to work alongside the sponsor and local research delivery team to support rapid study set-up.

Good practice principles when assessing, arranging and confirming local capacity and capability for CRN supported studies

  • NHS organisations - For studies on the NIHR Clinical Research Network Portfolio, our funding is available to support NHS organisations to undertake the activities of assessing, arranging and confirming local capacity and capability. To support a consistent approach to local set-up across the study, we have produced a set of principles for NHS organisations 
  • Sponsors and study coordinating teams - To further support a consistent approach we've also developed a version of the principles for sponsors and study coordinating teams, which describe the steps they should take to set-up sites on Network supported studies effectively.

Where does CRN support fit in relation to HRA Approval?

If your study is eligible for our support, we can support you with site identification and optimising study design for delivery in the NHS, as well as providing support with setting up and subsequently delivering your study within the NHS through our Study Support Service.

Our flowchart provides further information on the services that CRN provides to support the set-up and delivery of eligible studies.

To access our range of support, please ensure that you apply to the CRN as early as possible, ideally before submitting any other regulatory approvals, including your application for HRA Approval. Application for our support is made using our Portfolio Application Form in IRAS, or through our Central Portfolio Management System (CPMS) for commercial contract studies.

 

HRA Approval – further information

View our set of HRA Approval webinars which explain the role of the CRN in supporting sponsors and sites when setting up HRA Approval studies.

Feedback 

We value your feedback. If you have any comments on the CRN principles for assessing, arranging and confirming local capacity and capability or would like to share any feedback on your experience of this process please complete our feedback form