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Sponsorship and Grant Submissions

All research studies taking place within health and social care and/or involving NHS patients, their tissue or information (data) must have a Sponsor.聽

A 'Sponsor' is the organisation, which takes ultimate responsibility for the initiation, management (or arranging the initiation and management) and/or financing (or arranging the financing) for that research. The sponsor takes primary responsibility that the design of the study meets appropriate standards and that arrangements are in place to ensure appropriate conduct and reporting.

最准的六合彩论坛 and 最准的六合彩论坛H will typically sponsor studies where the investigator has a substantive or honorary contract with the institution and where there is at least one UK site. The decision as to which institute should sponsor a study is determined by the JRO during the sponsorship approval process. 聽

Healthy volunteer studies which are clinical trials of investigational medicinal products (CTIMP) will also require sponsorship. Other types of healthy volunteer study may not require sponsorship but will require a review by聽.

Please note that any studies or grant applications under review by the JRO that are dormant will be withdrawn and deregistered. This is defined as those which have not heard back from the study team within 12 months of initial registration. If desired, withdrawn studies can subsequently be reregistered and will be given a new local reference number. Any previous documents may have to be updated in line with regulatory updates and current best practice.

Please check the information below in the drop-down menus to identify the correct documents to draft and submit to the JRO to register your clinical research study, trial, or grant application.

Applying for Sponsorship

Determine which department should support your application

Is your study聽?听

  • No: You should discuss the proposal with you clinical or academic department. It is unlikely that your study requires the support of the JRO.聽Contact the JRO聽if you are unsure.
  • Yes:聽Your study will need to be reviewed to determine if 最准的六合彩论坛 or 最准的六合彩论坛H will sponsor. There are a few steps required to get to this decision. The JRO will help you here.聽A coordinator or advisor will be assigned to support you with the set-up of the study and determine the sponsor.
  • If your study is one of the following please make contact with the team specialising in these types of studies at聽ctimps@ucl.ac.uk:
    • Clinical Trial of an Investigational Medicinal Product (CTIMP)

    • Clinical trial involving an Advanced Therapy Investigational Medicinal Product (ATIMP)

    • Medical Device Clinical Investigation (requiring MHRA approval)

    • Medical Device / IMP combination studies

All these types of studies require MHRA approval and the Sponsor will be 最准的六合彩论坛. 最准的六合彩论坛 can also act as a legal representative for Sponsors of CTIMPs outside the UK. (Please note 最准的六合彩论坛H does not Sponsor CTIMPs or Medical Device Clinical Investigations). The team at CTIMPs@ucl.ac.uk can provide regulatory submission and trial management support to the Chief Investigator, and can provide Sponsor oversight of 最准的六合彩论坛 sponsored trials managed by CTUs external to 最准的六合彩论坛.

For all other studies (not requiring MHRA approval) email the team at uclhrandd@nhs.net.

The coordinator/advisor will support you with the grant application.

If you are unsure if your study is a clinical trial of an investigational medicinal product or a regulated device study, please refer to the MHRA decision tools and the FAQs section of this website.

Grant Submission

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聽clinical research聽and are likely to require 最准的六合彩论坛 or 最准的六合彩论坛H to act as a regulatory sponsor, should be reviewed by the JRO prior to submission (or聽where applicable, a clinical trials unit at 最准的六合彩论坛).

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 最准的六合彩论坛 or 最准的六合彩论坛H.

Grants managed through 最准的六合彩论坛

Researchers at 最准的六合彩论坛 should first read and follow the guidance from聽Research and Innovations Services聽on applying for funding from 最准的六合彩论坛. The required procedures for submission through 最准的六合彩论坛 systems should be followed. 最准的六合彩论坛 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聽SoECAT聽(where required by the funder). The聽聽from the JRO should be incorporated into the application managed through 最准的六合彩论坛 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鈥 notice for studies which are Clinical Trials of Investigational Medical Products (CTIMPs),聽Medical聽Devices聽Clinical Investigations聽that require MHRA approvals. A minimum of 4 weeks is required for all other studies.

Grants managed through 最准的六合彩论坛H

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.聽 The majority costs are likely to be incurred at 最准的六合彩论坛H rather than 最准的六合彩论坛. Where 最准的六合彩论坛 costs are required, researchers should follow the guidance of the necessary 最准的六合彩论坛 department and 最准的六合彩论坛 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聽SoECAT聽(where required by the funder).

聽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:

Clinical Trials of Investigational Medical Products (CTIMPs)聽and聽Medical聽Devices聽Clinical Investigations聽which require MHRA approvals.

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 聽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 最准的六合彩论坛 Research and Innovations Services (where applicable).

The coordinator will confirm 鈥渟ponsorship in principle鈥 and which organisation would act as sponsor (最准的六合彩论坛 or 最准的六合彩论坛H). 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.

  • Significant issues/risks/concern: an internal referral to JRO leads for sponsorship and finance maybe required

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

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

Once received, a coordinator will be assigned.

The coordinator will conduct a review which will indicate which organisation (最准的六合彩论坛 or 最准的六合彩论坛H) would act as regulatory 聽鈥淪ponsor in Principle鈥. 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 最准的六合彩论坛 or 最准的六合彩论坛H or costs from external providers maybe requested CRE/MPE reviews: 最准的六合彩论坛 insurers: in some cases, a study falls outside of the usual cover permissible under 最准的六合彩论坛鈥檚聽. This means an additional premium cost maybe required within the grant application (or agreement to cover this through other means)
Sponsorship Approval

The JRO coordinator or advisor assigned to your study聽will confirm full sponsorship and insurance cover and work with you to submit to the required聽regulators聽and ensure the correct documents are in place.

For studies which have been classified as Clinical Trials of Investigational Medicinal Products (CTIMPs) or Medical Device Clinical Investigation (requiring MHRA approval), your advisor will provide you with a list of required documents once they have discussed the study with you.

For all other studies, your coordinator will require聽the following information to begin the sponsorship process:

Further documentation maybe requested by the JRO. Additional documentation will be dependent on the type of study and number of sites and collaborators.

The sponsorship review process will commence. This may consist of support and advice in the following:

  • Study costing and financial management via the JRO finance team
  • Legal and contractual matters via the JRO legal team
  • Regulatory submissions聽via the JRO regulatory teams
  • Study management and oversight advise via the JRO quality assurance teams
  • Patient and Public engagement via the JRO PPI teams
  • Medicinal Product support and vendor auditing via the JRO regulatory, pharmacy and PV teams.
  • Confirmation of insurance cover

View a flowchart of the Non-CTIMP sponsorship process.

Image of the Sponsorship process flowchart

You can find sponsorship checklists, guidance and policies in the聽resources and templates pages.

At the end of the sponsorship process, you will be ready to submit the study to the relevant聽regulatory bodies聽and move onto the next stages -聽Assess, Arrange and Confirm.

Studies which use anonymous data from 最准的六合彩论坛H (only) may be eligible for a combined sponsorship and AAC process called the DAP-R. DAP-R is relevant for studies sponsored by 最准的六合彩论坛 or 最准的六合彩论坛H only. See our Data pathways at 最准的六合彩论坛 webpage聽for further information on the DAP-R and accessing data at 最准的六合彩论坛H.