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Grant applications

All studies which require a regulatory sponsor should have sufficient funding in place to cover its likely costs.

Grant applications which fall into the category of clinical research and are likely to require UCL or UCLH to act as a regulatory sponsor, should be reviewed by the JRO prior to submission (or where applicable, a clinical trials unit at UCL).

An organisation takes responsibility for the administration and management of the funds and terms contained within most grants. Grants for clinical research studies are processed through either UCL or UCLH.

Grants managed through UCL

Researchers at UCL should first read and follow the guidance from Research and Innovations Services on applying for funding from UCL. The required procedures for submission through UCL systems should be followed. UCL Research and Innovations Services will administer and manage the grant.

The JRO will advise on any regulatory and study management matters which may impact upon the funding requested in the application. The JRO will also advise on, and support the completion of, the SoECAT (where required by the funder). The feedback from the JRO should be incorporated into the application managed through UCL Research and Innovations Services.

At the end of this process, the JRO will provide the researcher with the necessary signatures and confirmations required for the grant submission.

The JRO will require at least 8 weeks’ notice for studies which are Clinical Trials of Investigational Medical Products (CTIMP), medical devices that require MHRA approvals and new interventions. A minimum of 4 weeks is required for all other studies.

Grants managed through UCLH

In some cases, a grant maybe processed through the NHS. The terms and conditions of the grant award will outline where this is expected or agreeable.

Such grants are managed through the procedures at the JRO.  The majority costs are likely to be incurred at UCLH rather than UCL. Where UCL costs are required, researchers should follow the guidance of the necessary UCL department and UCL Research and Innovation Services to obtain these costs.

The JRO will advise on any regulatory and study management matters which may impact upon the funding requested in the application. The costings team will also advise on, and support with the completion of, the SoECAT (where required by the funder).

 At the end of this process, the JRO will provide the researcher with the necessary signatures and confirmations required for the grant submission.

How to obtain JRO input to a grant application

Researchers with studies which fall into the following categories should contact the JRO to discuss their proposal prior to completing and documents:

  1. Clinical Trials of Investigational Medical Products (CTIMP)
  2. Medical devices which require MHRA approvals

Contact should be made via email:  ctimps@ucl.ac.uk

For all other studies, all researchers should complete the grant submission request form and checklist. Both, alongside any required documents should be sent to uclh.randd@nhs.net.

Once received, a coordinator will be assigned.

The coordinator will conduct a review which will indicate which organisation (UCL or UCLH) would act as regulatory  “Sponsor in Principle”. The coordinator will identify where additional costs may be required. These will relate to the management of the study such as archiving, regulatory fees, monitoring, supplies and audit.

In some cases, additional inputs maybe requested by the coordinator:

  • Collaborations or partnerships which involve commercial intent or significant partnerships: the advice from a JRO contracts manager will be sought
  • Specialist services: the input from other departments at UCL or UCLH or costs from external providers maybe requested
  • CRE/MPE reviews:
  • UCL insurers: in some cases, a study falls outside of the usual cover permissible under UCL’s current insurance cover. This means an additional premium cost maybe required within the grant application (or agreement to cover this through other means)
  • Significant issues/risks/concern: an internal referral to JRO leads for sponsorship and finance maybe required

The JRO coordinator and a specialist JRO cost accountant will work together to provide the final costs to the researcher for submission to the application. The cost accountant will also  provide support with SoECAT requirements.

The researcher is responsible for converting these costs accurately into the application and in line with the requirements of the funder and UCL Research and Innovations Services (where applicable).

The coordinator will confirm “sponsorship in principle” and which organisation would act as sponsor (UCL or UCLH). This confirmation should not be considered as a full sponsorship approval. Full approval is subject to the award of the grant and the successful completion and authorisation of a full sponsorship review which will be conducted by JRO once the grant has been awarded.

For Sponsor representative signatures, the signatory is the Director or Deputy Director of Research Support. For NHS finance signatures, the signatory is the JRO Head of Finance.