Feasibility/Expressions of Interest and
There is an understanding that information provided during the
set-up of commercial research is often of a confidential nature and
that a confidentiality agreement may need to be signed before the
information is provided on behalf of the Sponsor to CDDFT.
Confidentiality agreements are reviewed by the R&D Director
at CDDFT. These agreements are signed by the R&D Director
on behalf of employees of CDDFT as an organisation.
The Research Promoter at CDDFT can help Sponsors and CROs
identify suitable investigators to undertake commercial research in
the Trust. The R&D team work closely with investigators to
complete feasibility and/or expression of interest questionnaires
to ensure all information supplied is accurate.
A member of the core R&D team will attend site selection
visits where possible and can provide Sponsors/CROs with advice
regarding our local contract negotiation and approval
R&D contact: David Rollins (Research Facilitator):
01325 743376; firstname.lastname@example.org
Our support services are fully committed to enabling research to
be conducted within the Trust and work closely with the research
teams and R&D to enable smooth study set up and
management. For enquires related to pharmacy or labs please
see contacts below.
Pharmacy contact: Lynsey Stephenson: 01325 743119;
Laboratory contact: Tracy Matheson-Smith:
Contact R&D to find out specific contacts for other
Contracts & Finance
Study agreements and budgets must be reviewed by the
R&D Department prior to any signatures being obtained on the
contract. Sponsors/CROs are advised to send draft contracts and
budgets to the R&D Assistant Manager as soon as feasible to
avoid delays in the set-up of new commercial studies.
Ideally the model agreements that have been developed nationally
in the UK should be used. The use of modified model agreements or
Sponsor's own agreement may result in longer set-up times and legal
review charges, which will need to be met by the Sponsor.
CDDFT prefer to use the NIHR Industry Costing Templates to cost
all commercial research. The template should usually be completed
by the Sponsor/CRO in the first instance and then sent to sites for
review and to initiate the negotiation process. There are
templates for both pharmaceutical and medical device trials, but
these are also used to cost non-interventional trials by just
completing the relevant tabs.
For all requests to invoice or queries regarding invoicing
contact the R&D Team.
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 a 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.
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.
For clinical trials of investigational medicinal products
(CTIMPs) the Trust NHS Permission letter is referred to as the
'Amber' light letter and grants governance approval for the
trial. Pharmacy will issue the final 'green' light letter to
allow recruitment into the study once certain criteria have been
fulfilled. This process does not delay the recruitment
process. For information on this process contact the Clinical
Only on receipt of a letter of NHS permission and Sponsor site
initiation can recruitment to the study begin.
David Rollins (R&D Facilitator): 01325 743379;
Sarah Clark (R&D Administrator): 01325 743276; email@example.com
NHS Trusts are now required to measure and publish data
concerning their own performance on initiating and delivering
research. This information can be accessed here[NSN2]
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
Close out & Archiving
When the study is ready for close out a member of the core
R&D team should be included in the meeting to ensure all
financial and archiving arrangements have been finalised.
CDDFT have facilities for safe archiving of documents however,
should the Sponsor wish to archive their study documentation this
is also acceptable.
'I cannot commend the clinic enough. It is marvellous we
have this service at all and well done to you all.'
Patient, Coronary Heart Disease / Heart Failure Service, Shotley
Bridge Community Hospital