Feasibility Requests & Expressions of
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
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;
Laboratory contact: Tracy Matheson-Smith:
Contact R&D to find out specific contacts for other
Funding & Grants/Training
In order to fund a research project you may require the
assistance of an internal or external grant (other funding streams
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
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.
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
Only on receipt of a letter of NHS permission can
recruitment to the study begin
David Rollins (R&D Facilitator): 01325 743379;
Geraldine Brown (R&D Administrator): 01325 743087;
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
Centre for Clinical Research and Innovation
Darlington Memorial Hospital
Tel: +44 (0) 1325 743366
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