How do I get my study in the NIHR CRN Portfolio?

Non-commercial studies

As of 1 June 2010 the NIHR Coordinated System for gaining NHS Permission (CSP) is the sole entry point for studies applying for inclusion on the NIHR Clinical Research Network (CRN) Portfolio.

NIHR CRN Portfolio Application process

NIHR CSP (and hence NIHR CRN Portfolio application) is accessed via the Integrated Research Application System (IRAS).
• Within the IRAS Project Filter, Question 3a “In which country of the UK will the lead NHS R&D office be located?” should be answered with England, then,
• Question 5a “Do you want your NHS R&D application(s) to be processed through the NIHR Coordinated System for gaining NHS Permission?” will appear, to which you should answer “Yes”.
• This will result in a CSP Application Form appearing in the Project Forms menu.
The Chief Investigator / Study Coordinator should complete and submit the CSP Application Form.
The NIHR CRN Coordinating Centre Portfolio Team will make an initial assessment on NIHR CRN Portfolio eligibility. If the study is deemed potentially eligible for inclusion in the NIHR CRN Portfolio, a message will appear in IRAS requesting submission of the R&D Form.
The Chief Investigator / Study Coordinator should complete and submit the R&D Form which will be validated by the CSP Unit within three working days.
On receipt of the R&D Form the Portfolio Team within the NIHR CRN Coordinating Centre will assess the study against the NIHR CRN Portfolio Eligibility Criteria and deem the study eligible, potentially eligible or not eligible.
Potentially eligible studies will be considered for inclusion on the NIHR CRN Portfolio via the adoption process. The adoption process is undertaken by the relevant NIHR Clinical Research Network i.e. Primary Care, Topic-specific and Comprehensive Clinical Research Network.
Once confirmed eligible for the NIHR CRN Portfolio the relevant NIHR CRN i.e. Primary Care, Topic-specific and Comprehensive Clinical Research Network, will contact the Chief Investigator to collect the additional information required for study initialisation on the Portfolio Database.

If your study is already open

The NIHR Clinical Research Network (CRN) Coordinating Centre is no longer accepting applications for studies that have already started recruiting patients.

Commercially-funded studies

Industry sponsored studies
All Industry sponsored studies need to go through an adoption process to be considered for inclusion in the NIHR CRN Portfolio. We strongly suggest that companies engage with the appropriate NIHR Clinical Research Network at the earliest possible time, to benefit fully from the services available to adopted studies through the networks, including site selection and costing negotiations. Refer to the Industry webpages for more information.

Industry studies are required to complete a short NIHR CRN Industry Submission form, so there is no need to complete the Initial Study Registration Proforma.

Alternatively, the Portfolio adoption process can be initiated through the use of NIHR CSP for gaining NHS permissions. The Industry contact at the appropriate network will receive details of the study and will make the necessary arrangements to consider your study. If you have already applied for NRES Approval or R&D Approval, your study will not be able to access NIHR CSP.

Please note, CCRN Industry studies are currently being considered for adoption on a case-by-case basis until the full implementation of the Comprehensive Local Research Networks (CLRNs) and Specialty Groups is complete, to ensure there is adequate interest and CLRN infrastructure in place to support study set-up and delivery. Consideration of all CCRN Industry studies for adoption will be possible from April 2009.
Industry funded, non-industry sponsored studies
The information above for non-commercial studies (relating to the stage the study has reached) also applies to industry funded, non-industry sponsored studies.