香港六合彩

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 香港六合彩 or 香港六合彩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 香港六合彩).

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 香港六合彩 or 香港六合彩H.

Grants managed through 香港六合彩

Researchers at 香港六合彩 should first read and follow the guidance from聽Research and Innovations Services聽on applying for funding from 香港六合彩. The required procedures for submission through 香港六合彩 systems should be followed. 香港六合彩 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 香港六合彩 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 香港六合彩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 香港六合彩H rather than 香港六合彩. Where 香港六合彩 costs are required, researchers should follow the guidance of the necessary 香港六合彩 department and 香港六合彩 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:

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 香港六合彩 Research and Innovations Services (where applicable).

The coordinator will confirm 鈥渟ponsorship in principle鈥� and which organisation would act as sponsor (香港六合彩 or 香港六合彩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 (香港六合彩 or 香港六合彩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:

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:

• Evidence of peer review (if applicable)

• Draft protocol using the JRO templates

  • Observational trials and interventional studies
  • Data only studies
• Applicable draft Participant documents e.g., Participant Information Sheet, Consent聽, GP letters
• Details of any statistical engagement
• CV of the Chief Investigator or Student (where applicable)
• Draft Statement Of Activities and Schedule Of聽
• Evidence of funding (where applicable)
• Details of any collaborations with external parties, including commercial entities and suppliers
• Any conflicts of interest

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.

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 香港六合彩H (only) may be eligible for a combined sponsorship and AAC process called the DAP-R. DAP-R is relevant for studies sponsored by 香港六合彩 or 香港六合彩H only. See our Data pathways at 香港六合彩 webpage聽for further information on the DAP-R and accessing data at 香港六合彩H.