Setting up and running research studies
This page covers the main areas to think about when you are setting up a research study.
Seek advice on how to run your study
The NIHR Study Support Service can help you plan, set up and deliver your research to time and target in the NHS, public health and social care settings.
Contact the study support service around the time your study has been shortlisted by a funder. This will ensure you get the full range of relevant support for you and your study.
They can advise on:
- whether you can get delivery support from the NIHR Clinical Research Network
- other aspects of delivering your study, like attributing costs or recruiting participants
Additionally, the UKCRC Registered Clinical Trials Unit Network offers a one-day workshop designed for current and aspiring Chief Investigators, to empower you to excel in the conduct of clinical trials through effective collaboration with a clinical trials unit.
Develop your research team
Make sure your research team has the appropriate expertise. It needs to include:
- project management
- patient and public involvement
- statistics, academics
- health economics
- clinical or subject (where applicable)
Be Part of Research is an online service that helps members of the public understand what research is, what taking part might involve, as well as helping people find research studies and volunteer to take part.
Please make sure you read the guidance on roles and responsibilities before involving members of the public.
Collaborate
You may want to partner or collaborate with the life sciences industry or charities.
You can also engage and collaborate with experts in our research infrastructure, to develop and create opportunities for your own research. Our researchers have expertise in:
- experimental medicine
- early-phase translational research
- medtech
- in vitro diagnostics
- patient safety
- implementation research
Identify sites for your study
Our Study Support Service can help you to quickly and efficiently identify suitable research sites across the United Kingdom.
Contact your Local Clinical Research Network (LCRN) to get started. We will use our national network, alongside colleagues in devolved administrations, to gather expressions of interest from investigators at sites throughout the NHS, including primary, social and community care settings.
You can review the responses and engage directly with sites for more in-depth site selection discussions.
To access this support, please contact your Local Clinical Research Network directly. If you are a life sciences organisation, please get in touch with our Industry Support Team.
Queries regarding access to research infrastructure support outside of England, should be directed to the relevant national coordinating functions:
- Scotland: NHS Research Scotland (NRS)
Email: enquiries@nrs.org.uk
Email: portfolio@wales.nhs.uk
- Northern Ireland: Northern Ireland Clinical Research Network (NICRN)
Email: NICRNPortfolio@nicrn.hscni.net
Study delivery review
For all new studies, we undertake a study wide assessment to identify and highlight any challenges to study delivery before they occur.
For example, we may identify staff training or specialist equipment that should be made available to support your study.
We then share this information with all your sites to enable a proactive approach to study set-up. We will discuss and agree measures required to address any challenges.
Streamline your study set-up
Our Study Support Service will create and implement a study-wide action plan containing recommendations and key information to help sites open as quickly and efficiently as possible. We use our national network to share the action plan with all your sites.
The study-wide action plan serves as a central resource - enabling a ‘do once and share’ approach. It facilitates development of proactive solutions, encourages collaborative working, and ultimately helps to maximise successful delivery of your research.
As part of the Health Research Authority (HRA) approval process, all NHS sites are required to confirm that they have capacity and capability to deliver your research. For studies taking place within the NHS, the study-wide action plan also contributes towards the assessment process and helps to provide consistency in set-up across all sites.
Performance monitoring: Keep your research on track
Our Study Support Service will work with you to monitor the progress of your research against its recruitment target and timelines.
Our data systems collate site level information to provide study-wide oversight. This enables a proactive approach for identifying studies that require additional support to stay on track.
As part of this service, your study will be allocated a performance review lead. They will be responsible for monitoring the progress of your study through its life cycle. Your performance review lead will schedule regular review meetings, and they will be your main contact point while your study is open to recruitment.
Access data, patient cohorts or samples support
We fund a number of initiatives to help researchers access health data, identify participants for research, and access, store and analyse research samples.
Access to data
Clinical Practice Research Datalink (CPRD)
The Clinical Practice Research Datalink (CPRD) provides access to high-quality, anonymised primary care data for past and future public health and clinical studies. These include outcomes research, epidemiology and randomised controlled trials.
The primary care data are linked to a range of other health-related data to provide a longitudinal, representative UK population health dataset.
CPRD data and services can be highly tailored to meet your specific research needs.
NIHR Health Informatics Collaborative
The NIHR Health Informatics Collaborative (HIC) provides access to high-quality, longitudinal secondary care datasets for translational research. Datasets are available in a number of clinical areas:
- cardiovascular medicine
- cancer: breast, colorectal, lung, ovarian and prostate
- critical care
- hearing loss
- infectious diseases
- hearing loss
- musculoskeletal
- renal transplantation
- viral hepatitis
ScanMedicine
ScanMedicine is a comprehensive database of clinical trials and medical device information. Researchers can use this database to gain an overview of the research landscape in their area of interest, to support planning research and building collaborations.
You can simultaneously search 11 major health databases across the globe for up-to-date information on what new medicines, devices and diagnostics are on the horizon. It was developed by the NIHR Innovation Observatory.
Find out more about ScanMedicine
Clinical Record Interactive Search (CRIS) and the Dementia CRIS (D-CRIS)
The Clinical Record Interactive Search (CRIS) and the Dementia CRIS (D-CRIS), based at the NIHR Maudsley Biomedical Research Centre, provide rapid access to pseudonymised mental health clinical records held in NHS systems.
This allows researchers to search structured and unstructured free-form clinical data, to swiftly investigate hypotheses and define anonymised patient cohorts.
In addition, some patients have given pre-consent to be contacted about research projects from information in their records, allowing targeted recruitment for trials and observational studies.
Find out more about CRIS.
Access to patient cohorts
NIHR BioResource
The NIHR BioResource is a panel of over 200,000 healthy volunteers and patients with common and rare diseases who are willing to be approached to participate in research studies investigating the links between genes, the environment, health and disease.
The NIHR BioResource can help you identify and recruit study participants who have been characterised by genotype and phenotype.
Find out more about the NIHR BioResource.
Access, storage and analysis of research samples
The UK Clinical Research Collaboration (UKCRC) Tissue Directory
The UK Clinical Research Collaboration (UKCRC) Tissue Directory is a free online resource that catalogues the different types of human sample resources across the UK. For example, biobank, cohort, biorepository, clinical trial.
Researchers can search the directory by gender, age, and disease, to either find banked samples or resources that can acquire bespoke collections.
Find out more about the UKCRC Tissue Directory.
NIHR National Biosample Centre
The NIHR Biosample Centre provides a high quality, high capacity service for collection, processing, storage and analysis of biological samples from biomedical research.
Find out more about the NIHR Biosample Centre.
MRC-NIHR National Phenome Centre
The MRC-NIHR National Phenome Centre has world-class metabolic profiling techniques for advancing academic and clinical research in personalised medicine, diagnostics and nutrition.
The centre offers a wide range of analysis services to researchers, from broad profiling untargeted assays through to targeted assays. These services are offered on a collaborative project basis or as a fee-for-service offering.
Find out more about the MRC-NIHR National Phenome Centre.
Access facilities for early stage research
The NIHR funds research infrastructure to support researchers with the delivery of early stage experimental medicine research studies. Our funding goes towards purpose built facilities in the country’s leading NHS hospitals and universities and a skilled workforce of researchers and clinical trial support staff.
Our facilities and expertise in research delivery are available to researchers who want to deliver experimental medicine research.
Access our facilities
NIHR Clinical Research Facilities (CRFs) are dedicated and purpose built facilities in NHS hospitals where researchers can deliver early phase clinical trials. The 22 facilities around England have cutting-edge technologies and access to patients.
Find out more about our facilities.
NIHR CRFs have skilled clinical trial support staff who can support complex or high intensity experimental research. The facilities are supported by the UK Clinical Research Facility Network, which provides best practice guidance and tools to ensure each CRF delivers clinical trials of the highest standard.
The Experimental Cancer Medicine Centres (ECMCs) are a network of world-leading scientists and clinicians who bring together expertise and techniques to support the delivery of early phase cancer trials. The NIHR funds 14 ECMCs across England in close partnership with Cancer Research UK.
Find out more about our experimental cancer research network