Weekly assessments
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- Confirmation of having taken medication (reminder sent daily for first two days then weekly)
- AE check
- Work pattern
- Symptom severity (score)
- Self-reported recovery
- Incidence of health care usage
Downloads:
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- Paper-based weekly assessment form
- Link to web-based weekly assessment interface
Participant documents
Site documents
Manuals:
- TPM
- Pharmacy manual
Forms:
- Current paper based CRF
- Weekly assessment document (paper-based)
- Logs (please add what’s relevant i.e sample logs)
- Include site file documents?
- Prolific prescription form
- SAE form
- Pregnancy form
Tracking, Reporting and Oversight
Our EDGE Support Team support all elements of EDGE use and user engagement across the trust – including training, query resolution and complex site or study mapping support.
Intellectual Property
Human Resources
The team also processes research passports which allow non-trust employed researchers access to research carried out by the Trust.
Costings and Finance
They can support calculation of costings for projects not on the CRN portfolio, supply finance sign-off for grants and approve recruitment via the Trust. They will also support you with invoicing, and provide you with a cost code so you can start spending your grant.
Communication and Dissemination
They can advise BRC-funded researchers on correctly acknowledging funding and support and help all researchers to disseminate their research by connecting them with communications colleagues across campus and university.
Research Registration and Governance
All Studies
All research taking place at CUH with patients or staff needs to be registered through the R&D office. The Research Governance Team can review research applications and authorise sponsorship of clinical research. They will guide you through the necessary regulatory submissions and work with commercial and non-commercial entities to facilitate set-up and delivery of high-quality clinical research. For studies that have not undergone assessment of scientific quality as part of the funding process, the CUH Research Advisory Committee will undertake independent expert review.
Data Studies
The Trust supports the ethical use of health and research data for research purposes. Our Research Governance Clinical Informatics Lead can help researchers navigate the regulatory and legal requirements for data studies and has particular expertise in research relating to secondary uses of data and consent.
Investigational Medicinal Products, Medical Devices and Non-CTIMPs
The NIHR UKCRC registered Cambridge Clinical Trials Unit (CCTU) collaborates with investigators in the planning and conduct of high-quality research projects included in their diverse portfolio. Administrative resources offered for full collaboration include all aspects of research (project) management from funding applications, research approvals and site set-up through to data management, statistical analysis and reporting. In addition the CCTU Regulatory Team undertakes all delegated Sponsor responsibilities for Cambridge-sponsored CTIMPs.
Patient and Public Involvement (PPI)
Patients and the public can be involved in your research right from the very earliest stages, continuing throughout a research project. The PPI Team can advise on PPI strategy and signpost to training and further resources.
Speeding up the diagnosis of COVID-19 in a hospital setting using a SAMBA II
The first part of the study will evaluate the accuracy of the new SAMBA II-based test and whether it speeds up the diagnosis of COVID-19 in a ‘real-time’ hospital setting at the point of care.
The second part will investigate a point of care finger prick ‘antibody’ test of the blood, to determine how quickly markers of immunity appear following infection and a positive SAMBA test. These antibody tests will be important for understanding which patients and staff have already had the infection, and may be safe to return to work following recovery.
Research nurses from the NIHR Cambridge CRF are collecting samples from patients with suspected COVID-19 to support the COVIDx study, using the SAMBA II machine to test nasal and throat swabs to determine if a patient has COVID-19 and if the new device is an improved source of testing.
The SAMBA II test can provide extremely reliable results in less than two hours, meaning decisions about clinical care or self-isolation can be made much more rapidly. The antibody tests require serum from blood samples, which will be tested in specialised facilities at the Cambridge Institute for Therapeutic Immunology and Infectious Diseases (CITIID).
Once the two diagnostic tests have been validated in patients with confirmed COVID-19, the study will enrol a second group of participants – healthcare workers. The SAMBA II test will be able to quickly identify staff who are positive for COVID-19, even if they have no symptoms, allowing them to self-isolate or access treatment if required.
This is an abridged version of the news item posted on our website on April 17, 2020.
Research Design, Funding and Feasibility
The Research Design Service East of England can advise on all aspects of research design, from methodological considerations to statistical requirements for applied Health and Social Care research grants, with particular expertise in National Institute for Health Research (NIHR) awards. They can review grant/funding proposals and also provide support and practice for mock interview; a requirement of NIHR Doctoral and Advanced Fellowships.
The Cambridge Clinical Trials Unit can advise on all CTIMP and non-CTIMP research trial design and funding options.
The NIHR CRN Portfolio Support Manager can also advise on study feasibility, SoECAT completion and CRN Nurse support for studies intended to be adopted onto the portfolio.
Urgent Public Health Research Studies for COVID-19
National Institute for Health Research (NIHR)
UK Government response
Health Research Authority (HRA)
Update on clinical research during the COVID-19 outbreak
We are reviewing all of our clinical research with Cambridge University Hospitals (CUH) and the University of Cambridge. Each study is being assessed on a case-by-case basis to minimise risks to participants either from continued participation in or disruption to a trial that forms part of their clinical care.
Some studies will need to pause or wind down to release staff for clinical roles and sample processing infrastructure to support the NHS.
Principal Investigators:
Chief and Principal investigators should review their studies and assess the risk to participants posed by COVID-19. Following risk assessment, please confirm your proposed mitigations or actions with Professor John Bradley, Director of Research, as soon as possible.
Research Participants:
Research participants will be contacted by their study team with updates about any changes to the study they are enrolled in. Please contact your study team if you have any further questions about your study or your participation during these events. Participants who believe they have COVID-19 symptoms should follow Department of Health and Social Care advice and contact their study team.
Patient and Public Involvement (PPI):
CUH is committed to supporting the research effort against COVID-19, and patients and the public will have a particularly valuable role as we embark on this. The PPI team are working remotely, but are still available to speak to researchers who need assistance with PPI for their grant applications or documentation reviewed by the CUH PPI panel. Our panel has over 70 people who are willing to review research-related documents and this service is still available, with our panel members very committed to continuing their support for researchers during this period.
Non-essential visits to the campus are not permitted at this time. As such, we have cancelled all in-person meetings and training that were planned through to the summer. This will continue to be reviewed as the situation changes. All filming and work experience in our research buildings have been suspended/ cancelled due to the current restrictions in place.
The PPI and communications team are also investigating options to run their training sessions and other PPI activities online.
If you need any assistance contact the PPI team: ppird@addenbrookes.nhs.uk
COVID-19 research studies at CUH
Chief and Principal Investigators of studies have been reviewing whether part or all of their studies need to be put on hold. Many existing studies are now suspended, and the NIHR Clinical Research Network is pausing any studies that are not nationally prioritised COVID-19 studies.
The NIHR has emphasised the need to prioritise COVID-related work, and are putting in place mechanisms for fast-tracking nationally prioritised studies through HRA and MHRA. A COVID-19 and Clinical Research Oversight Group has been established under the governance of the NIHR Cambridge BRC and will review nationally prioritised studies to consider which can be supported locally with the available resources.
The group will also consider proposals for studies to be sponsored by Cambridge University Hospitals and / or the University of Cambridge, but these are likely to need to have national reach or build on unique local capability to meet the threshold for fast -tracking through HRA / MHRA approval processes.
Professor Ian Wilkinson, Director of the Cambridge Clinical Trials Unit (CCTU), is also establishing a committee to review proposals for clinical trials related to COVID-19.
If you have questions, research proposals or clinical trials that you wish to be considered please contact Covid19research@addenbrookes.nhs.uk in the first instance.
New National guidance for prioritising funding and support for COVID-19 research across the UK
Given the extraordinary pressures currently being faced by the health and care system, we must also ensure that we are making best use of the limited resources and capacity available to support research.
We will do this by establishing and implementing a single, national process that will allow the Chief Medical Officer (CMO) / Deputy Chief Medical Officer (DCMO) for England to draw on expert advice to prioritise the COVID-19 studies which hold the most potential for tackling the challenges we face.
This process will cover all funded studies, irrespective of whether they are funded by the public sector, industry or charities and also, in partnership with UKRI, studies that require funding. It aims to prevent duplication of effort and to ensure that the capacity of the health and care system to support research is not exceeded.
Details of the process and the new single point of entry for prioritising COVID-19 studies an be found here.
With regard to HRA approvals, researchers should make an application through the national prioritisation process first and will be signposted for expedited regulatory approvals so that approval review can progress in parallel to the system of assessment leading to a view from CMO/DCMO on prioritisation.
All NHS Trusts, health and care providers and universities will need to prioritise support for studies which have been nationally prioritised. A live list of these studies is being collated. Organisations may support COVID-19 research activity only when this does not impact on the system’s ability to recruit participants and/or provide the resources (including staff, samples and data) needed to support nationally prioritised research. Organisations will be expected to pause any local studies that impede their ability to contribute to national research efforts.
- Government support for research related to COVID-19: Find out how to get your study nationally supported or funded as high priority COVID-19 Urgent Public Health Research.
- COVID-19 and Clinical Research Oversight Group CUH: This has been established under the governance of the NIHR Cambridge BRC and will review nationally prioritised studies to consider which can be supported locally with the available resources.
- NIHR response to COVID-19 pandemic: All NIHR updates on one page.
- Covid-19 response from the NIHR Cambridge BRC: Information for researchers, academics and clinicians on clinical research taking place on the Cambridge Biomedical Campus during the COVID-19 outbreak.
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