Commercially sponsored research
Hosted studies
At UHDB we host both commercial and non-commercially funded research, in a wide variety of specialities, with studies ranging from observational studies through to Clinical Trials of Investigational Medicine Products (CTIMPs) and device trials. We are currently recruiting to national and international studies, as well as home-grown research.
Opening a research study
Before opening a hosted study at UHDB, the study must be reviewed to ensure that there is capacity and capability to undertake the research. The Study Set Up Team is instrumental in completing this review and putting in place the necessary local approvals. The team will:
- Provide advice, support and guidance throughout the study setup process
- Ensure that the study is compliant with all relevant regulations and has all the necessary regulatory approvals
- Work closely with the research clinical delivery teams to ensure that the study is set up and managed effectively
- Liaise with support departments to ensure that any additional research-specific procedures, investigations etc can be accommodated
- Undertake a review of the study budget and contract to ensure that appropriate funding and resources are in place
- If you have a study you would like to open, please contact us as soon as possible via uhdb.researchgov@nhs.net and we will support you with set-up
- Ongoing study management
- The Setup Team will also provide support once the study is open, including the review and processing of amendments. All study amendments must be sent to uhdb.amendments@nhs.net
Expressions of Interest (EOIs)
The expression of interest process is intended to facilitate the rapid identification of interested sites for commercial sponsors. It is to help sponsors gather high level feasibility rapidly and to give them the information to be able to follow up with more detailed feasibility with those interested sites that meet minimum requirements (from the sponsor’s perspective).
As a site it is important to remember that this process is just an expression of interest and is not in any way a binding agreement. The sponsor is providing a limited set of information for the site to make an assessment on. If the site is interested and the sponsor wants to take it further the sponsor will then follow up with a confidentiality agreement so that they can send the site more detailed and confidential information such as a full synopsis or full protocol.
Expressions of Interest are sent out by the Study Set Up Team in R&D, if you would like to receive Expressions of Interest for your disease area, please let them know via uhdb.expression-of-interest@nhs.net
Likewise, if you have been contacted about a new study, contact the team and we can help with the completion of any documents.
Confidentiality Disclosure Agreements
UHDB R&D, in line with HRA guidance, considers that the confidentiality disclosure agreement of preference is the national mCDA template - (supported by the ABPI) for use in commercial studies.
This CDA is intended to reduce the time taken to negotiate specific terms and to ensure that the CDA is consistent with the terms of the model Clinical Trials Agreement which would be used for any study going forwards. We consider this a sensible approach to ensure swift protocol disclosures and site set up. This CDA can be signed without delay.
Should a company wish to use their own local template, this will require legal review and may cause delays.
Please send all CDA requests to: uhdb.researchgov@nhs.net