Setting up Research at CDDFT

Feasibility/Expressions of Interest and Confidentiality

Confidentiality Agreements

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.

Feasibility Procedures

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 processes.

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

Support Services

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; 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

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 Trials Pharmacist.

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; d.rollins@nhs.net

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

Study Performance

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]

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

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.