It is national policy that all health and social care research has a Sponsor. A sponsor is legally required for all clinical trials under the Medicines for Human Use Clinical Trials Regulations 2004 and the Amendments Regulations 2006.
What is the Sponsor’s role?
- To take overall responsibility for the research
- Ensuring appropriate indemnity or insurance for the study
- Ensuring patient / participant safety and rights
The sponsor is not necessarily the funder and many funding bodies are unable to provide sponsorship.
When can the RD&E act as sponsor?
Where there is no third party sponsor, the Royal Devon & Exeter NHS Foundation Trust (RD&E) will usually act as sponsor for research where:
- The chief investigator (CI) is a substantive employee of RD&E
- The chief investigator (CI) is a clinical academic practising in the RD&E with an honorary RD&E contract.
- The research involves significant clinical resources, staff or patients from the RD&E
How do I apply for the RD&E to be the sponsor?
If you would like the RD&E to sponsor your study, please contact the Research & Development (R&D) Department as early as possible via the R&D generic email account rde-tr.Research@nhs.net. The Investigator must submit an application for Trust Sponsorship to R&D, supported by the following documentation:
- Trial proposal/ draft protocol/ grant application
- MHRA confirmation of CTIMP status (if appropriate)
- Outline funding plan
- Evidence of scientific peer review (if available)
Before agreeing to act as sponsor, RD&E will need to assure itself that the study is within the sponsorship scope and of the scientific quality of the study and that the protocol contains all required information. Sponsorship applications are discussed fortnightly and should be submitted 7 calendar days before the meeting. For meeting dates please contact R&D.
By confirming Trust Sponsorship in Principle, the RD&E is not giving permission for the study to commence. Sponsorship in Principle is conditional on all relevant approvals being in place and provision of adequate funding. Sponsorship will only be granted once any issues raised by the risk assessment have been addressed. R&D will issue the CI with written confirmation of Sponsorship in Principle which will also outline CI responsibilities and a link to the electronic library of R&D SOP’s.
What are my on-going obligations?
The Chief Investigator is the overall lead researcher for a study. Ongoing responsibilities include:
- All amendments are provided to the sponsor for review before submission to NHS REC and HRA, and the MHRA and NHS trusts as applicable.
- All annual progress reports, development safety update reports (CTIMPs only) and end of trial/study notifications must be sent to/reviewed by the sponsor.
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