Conducting research at CUH

We are responsible for overseeing all the biomedical research which takes place on our campus in so far as it involves our patients, their data or tissues, or where it uses NHS facilities and our staff.

Biomedical research taking place with patients at Cambridge University Hospitals includes the following activities:

testing a new formulation of a drug therapy
testing a new device or tool to either improve diagnosis or to improve recovery
testing a new method of delivery of a drug or treatment
asking patients to complete qualitative questionnaires
asking patients to take part in a series of tests, e.g. measuring their heart rate and recording the results

Any research involving patients at the hospital means that you will need the help of the research and development governance team. This team will guide you through the research application process to ensure that what you do is safe, ethical and complies with all the necessary legislation governing research on people.

Our Mission

To facilitate excellence in medical research by providing helpful and competent support on all matters of research governance, administration and management.

Before you start

Commercial Research update

From Mid-October 2023 as part of work to improve the set-up of commercial studies in the UK, local contract negotiation is changing in Stage 2 of the National Contract Value Review (NCVR) which was implemented in response to Lord O’Shaughnessy’s independent review (opens in a new tab) of commercial clinical trials

What is changing?

For all studies submitted from Sunday 1 October 2023:

Regulatory and costings submissions will be made at the same time
The budget will be shared with the lead applicant (lead NHS site) for national costing. This finance schedule will be put into a new template contract appendix, to be shared with sites
There is no local site budget negotiation as the financial appendix is mandated for use, unmodified.
From 18 October, any contract not already agreed will need to follow NCVR stage 2.
The aim is to speed up commercial trial setup so sites can concentrate on assessing resource to provide capacity and capability to deliver the trial.
Further information available here (opens in a new tab).

Which studies are affected?

All commercial contract research to take place in the NHS across the UK is planned to be in scope of NCVR. There are some exceptions for stage two: phase I-IIa, advanced therapy medicinal product (ATMP) studies and studies carried out in independent contractor primary care.

Studies excluded from stage two in the NCVR process will be included as soon as possible

Health research authority (HRA)

The role of the health research authority (HRA) is to protect and promote the interests of patients and the public in health research and to streamline the regulation of research. The HRA are also responsible for the NHS research ethics Committees.

HRA Approval is required for all research to commence in the NHS in England. It comprises a review by a Research Ethics Committee (REC), and an assessment of regulatory compliance and related matters undertaken by HRA staff located in centres around England.

HRA Approval includes a study-wide review in line with UK-wide agreed standards and also new assurances, including the coordination of clinical support assurances for radiation and pharmacy. When HRA Approval is fully implemented, sites have to confirm they have the capacity and capability to undertake the study. Once HRA Approval is in place and local capacity and capability is agreed, sites can confirm with the sponsor their readiness to recruit and the study can then start at that site.

Applications for HRA approval are made using IRAS (Integrated Research Applications System) and are e-submitted directly to the HRA through IRAS. Study documents to sites are provided directly from the sponsor for most study types. HRA studies will not appear in the NIHR CSP module.

Guidance is available on the HRA website (opens in a new tab). This includes guidance for applicants and NHS organisations and illustrative examples.

Please email the research development department with any enquiries.

Applications

The application forms for the submissions to all review bodies can be completed through the Integrated Research Application System (IRAS). This national on-line system captures all the necessary information for the relevant approvals. It replaced previous forms such as the NRES form and COREC form.

The key IRAS forms are:

REC application form
Research and Development application form
Site specific information (SSI) form

Once ready, the forms can be signed electronically and submitted to the applicable review bodies.

Access the integrated research application system (IRAS) (opens in a new tab)

GCP training

Good Clinical Practice (GCP) training

If your training is up for renewal, the R&D team offer three GCP training courses via the NIHR website:

GCP Full Course
GCP Refresher Course – for staff who have undertaken the full GCP course within the last three years or have renewed their training within the last three years.
Fundamentals of Clinical Research Delivery for Laboratory Staff – for lab staff after completion of the full/refresher GCP course.

NIHR Learn is a national resource co-developed with and approved by the MHRA and is accepted by most research sponsors. Courses can be completed in your own time and followed up with a webinar/ face-to-face consolidation workshop (opens in a new tab). All courses, including the consolidation day, are free of charge to NIHR, NHS and UK university staff.

Book your GCP training

You can book your GCP course via the NIHR website (opens in a new tab). If you are unsure about your GCP certificate, when it is due for renewal or any other queries, contact CUH GCP Training

Your GCP certificate

Once you have completed your GCP training, your certificate should be recorded by your department and updated on Q Pulse/ EDGE. A copy of your GCP certificate will also need to be sent to the R&D department at cuh.gcptraining@nhs.net, which has now transitioned from ReDA to EDGE for study set-up and management procedures for all portfolio and non-portfolio research studies taking place at Cambridge University Hospitals.

As part of this changeover, CV and GCP certificates will also gradually move over and be managed via EDGE as part of the research and quality management system.

Please note, this does not apply to Trial Master Files, Investigator Site Files and Pharmacy Files.

EDGE training

Local Portfolio Management System (LPMS)

Since 2017 Cambridge University Hospitals (CUH) have been using an LPMS called Edge to capture clinical trials data and support the delivery and maintenance of research at CUH.

If you work on studies adopted to the NIHR Portfolio, it is a mandatory requirement to upload patient recruitment data to Edge.

IMPORTANT:

LPMS / Edge data now feeds and flows directly to the Central Portfolio Management System (CPMS)
Edge covers Portfolio study recruitment only

EDGE End-User Trainings and Drop-in Sessions – 2025

The CUH EDGE Team are holding a series of both online and class-based trainings combined with Drop-in sessions throughout 2025 for all research staff.

EDGE End-User Training is suitable for those new to EDGE and those who would like to refresh their knowledge on adding or updating participant records on Edge for their research studies at CUH.

Drop-In Sessions are for all research staff already using Edge who need support on general use of the Edge system.

Research staff can ask for guidance and support on:

GCP and CV Certificate uploads
Participant recruitment uploads and related queries
A quick refresh demo in “How to” do a particular task in Edge
Resolving any queries related to Edge use.

Upcoming dates and times for 2025 are:

Wednesday 8th January, 14:00-16:00 MS Teams (first hour training, second hour drop-in)
Friday 31st January, 09:30-12:30 Room DK10, Deakin Centre (first two hours training, third hour drop-in)
Wednesday 12th February, 14:00-16:00 MS Teams (first hour training, second hour drop-in)
Monday 24th February, 09:30-12:30 Room DK10, Deakin Centre (first two hours training, third hour drop-in)

Please find the remaining dates for 2025 in the Registration Form (opens in a new tab), or contact the CUH EDGE Team (cuh.edge@nhs.net).

Starting a project

If you are thinking about starting a research project, take the opportunity to speak to the research development department as early as you can, even if all you have is an idea.

They can offer advice and help with protocol submission and advise you on what information you will need to submit a research application.

Setting up a project

Funding

Once a project has been authorised to take place at the trust, the Research and Development Department provides ongoing support for investigators and is happy to answer queries on all aspects of research.

The pages in this section will provide advice and guidance on the various elements involved in research especially in the early stages of study set-up. This can include providing training, issuing honorary research contracts or letters of access, or even providing funding guidance for grant applications. We also have an innovation scout within the department to help you with any innovations queries.

National Institute for Health and Care Research (NIHR)

The National Institute for Health and Care Research's vision is to improve the health and wealth of the nation through research. Visit the NIHR website to find out more about funding opportunities (opens in a new tab), including funding for research studies and training / career development.

EU funding

NIHR Research Support Service

Thinking of applying for research funding? The NIHR Research Support Service (opens in a new tab) (RSS) provides free and confidential advice to develop funding applications within the remit of the NIHR, including clinical, applied health and social care research, and post-award advice to award holders.

Access to support, advice and expertise is available for all researchers across England applying to NIHR research programmes or research training awards as well as to non-NIHR funders such as charities.

The RSS is delivered collaboratively through eight hubs, each a partnership of research groups and organisations, linked to topics rather than geographies.

All hubs support a broad range of research designs, from pre-application through to post-award delivery, as well as providing specialist topic or methods expertise. There are also specialist centres with expertise in public health and social care research.

In the East of England we will have our own contact for researchers based here, to facilitate access to RSS support.

If you have a general question about the RSS you can contact the National Collaborative team on NIHR-RSS@contacts.bham.ac.uk.

SoECAT infographic to help researchers

Are you a researcher working at CUH and is your study adopted to the NIHR RDN portfolio?

Have you completed your SoECAT (Schedule of Events Cost Attribution Template)? This captures and calculates the different activities and related costs associated with clinical research in a standardised and consistent way. All researchers applying for grants must complete a SoECAT as part of their application - as it gives funders reassurance that the site level activities within the study have been attributed correctly in line with DHSC AcoRD Guidance.

The NIHR CRN East of England (now the NIHR East of England Regional Research Delivery Network (opens in a new tab)) provided a handy infographic that details the steps needed to correctly fill out your SoECAT (see image below).