Research Support

Feasibility Requests & Expressions of Interest

Depending on the study and Sponsor there may be a site feasibility questionnaire or expression of interest form for the Investigator to complete.  These questionnaires are used by the sponsoring company to gather information about how suitable a Trust and Investigator will be for the study in question. They also give the Investigator an opportunity to raise any concerns or issues about the study to the sponsor. It is important that we are able to provide accurate and detailed feasibility information to sponsors in a timely manner, the R&D department can support with the completion of this.

R&D contact: David Rollins (Research Facilitator): 01325 743376; d.rollins@nhs.net

Support Services

You may require the support of other services within the Trust to successfully set up and manage a research project.  It is important that these services are contacted early on in the set up stage to ensure the study is feasible.

Pharmacy contact: Lynsey Stephenson: 01325 743119; lstephenson2@nhs.net

Laboratory contact: Tracy Matheson-Smith: t.matheson-smith@nhs.net

Contact R&D to find out specific contacts for other services: cdda-tr.research@nhs.net

Funding & Grants/Training

In order to fund a research project you may require the assistance of an internal or external grant (other funding streams are available).

Contracts & Finance

Sponsors of many studies will require the Trust to enter into a contract with them before the study begins. For the majority of studies, the contract will be in the form of a study specific Clinical Trial Agreement. This agreement would usually be between the sponsoring company and the Trust, but a Contract Research Organisation (CRO) may also be party to the agreement if some of the study management has been outsourced by the Sponsor.

The contract will include a financial appendix and a payment schedule for the study, detailing how the Trust will be reimbursed for their work in undertaking the study.  These costs are usually reimbursed based on activity undertaken and payments are made following invoices from the Trust.

All research contracts and budgets should be reviewed by the R&D department well in advance of the planned start date for your study. Investigators are advised to put commercial companies in touch with the R&D department as soon as possible.

NHS Permissions & Governance Review

Any research studies conducted in the NHS must have permission from the research governance department (R&D) in that Trust to undertake their research study.

Providing that all the appropriate study documents have been submitted it is expected that NHS permission (R&D approval) will be granted without delay.

The process of submitting for NHS Permission is slightly different depending on whether your study is eligible for inclusion on the National Institute for Health Research (NIHR) Portfolio.   More details on the NIHR portfolio and eligibility criteria can be found on their website.

• Studies eligible for inclusion on the NIHR portfolio: After all regulatory approvals are in place and the R&D form has been completed by the lead site for the study, a Site Specific Information (SSI) form will need to be submitted with accompanying documents for each NHS organisation that will take part in the research study. The SSI form will need to be completed by the Trust study team and transferred to the R&D Facilitator for submission through IRAS.
• Studies not eligible for inclusion on the NIHR portfolio: the SSI form and associated documents need to be completed and submitted to the R&D Administrator.

After submitting an application, the R&D department will perform a governance review on the project. The designated member of staff may be in contact regarding the application.

Only on receipt of a letter of NHS permission can recruitment to the study begin

David Rollins (R&D Facilitator): 01325 743379; d.rollins@nhs.net

Sarah Clark (R&D Administrator): 01325 743276; sarah.clark35@nhs.net

Amendments

During the course of a study there may be amendments to study documentation which require continued NHS permission to be granted.  The changes within the amendment should only be implemented when this permission has been received.

For enquires regarding amendments contact cddft.research-amendments@nhs.net