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e-Pathway: From Idea to Proposal
This is the most important part of a research project. Invest time and effort in critiquing your research idea, formulating a testable hypothesis or causal pathway, developing the most efficient methodology, and defining outcomes. This section describes the people, skills and tools you will need.
Establishing your research team
Establishing your research team
Successful research is dependent on good teamwork between individuals with relevant expertise. Crucially, this includes those with lived experience of diseases or services The Health Research Authority (HRA) publishes guidance on roles and responsibilities that should be considered early on, including the roles of the Sponsor, Chief / Principal Investigator and the data controller.
Your research team could include members from other academic institutes who may require a research passport to gain access to the NHS.
UoB Human Resources manage research passports for UoB researchers and can be contacted via the HR portal (UoB login required).
For information on applying for fellowship funding, please see the Research Fellowships in the College of Medicine and Health.
Training and competencies
Training and competencies
High-quality clinical research is underpinned by continuous staff training and development (UoB Principles of GCP for Clinical Research (UoB-GCP-POL-001) [Word - 303 KB]). All those involved in research must be qualified by education, training and experience, or under the supervision of a suitably qualified person, to perform their tasks. This can be evidenced through a CV and/or job application form with proof of relevant education and experience and a signed & dated job description which specifies the tasks assigned to the staff member. Please refer to the UoB Training SOP (UoB-TRN-SOP-001) [Word - 82 KB] for further information.
For laboratory research involving human biomaterials, competence also includes both the use of equipment and performance of assays, and supervising others in those tasks. Please refer to the UoB Laboratory Set Up and Management SOP (UoB-CRL-SOP-001) [Word - 360 KB] for further information.
What is Good Clinical Practice (GCP) and do I need to be trained in it?
GCP is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical research that involve the participation of human volunteers. Compliance with the conditions and principles of GCP provides public assurance that the rights, safety and wellbeing of research participants are protected and that research data are reliable.
Anyone involved in a CTIMP (Clinical Trial of an Investigational Medicinal Product) must receive training in GCP that is commensurate with their roles and responsibilities. As a minimum, anyone involved in the day-to-day (site) management of a CTIMP (e.g. chief investigator, research nurse, trial coordinator) are required to complete the National Institute for Health Research (NIHR) GCP training, and must complete the GCP refresher training every three years. Likewise, laboratory staff working with clinical trial samples will require GCP in the Laboratory training commensurate with their role and responsibilities and refreshed at least every 3 years.
Will you be working with human tissue?
For those researchers seeking the UoB‘s sponsorship for projects involving human tissue samples, evidence of specific training on the use of human tissue in research will be required (such as the completion of the HRA online Human Tissue training or MRC online Human Tissue training).
Further information
See the UoB Clinical Research Quality Manual (UoB-CQM-POL-001) [Word, 559 KB] for more information on the clinical research training policy. Also, you can visit the links below to find a wide range of training opportunities for research staff.
People who will help with the grant application
People who will help with the grant application
The University's Research, Strategy and Services Division (RSSD) provides strategic input and support for researchers who are preparing funding applications.
Patient & Public Involvement (PPI)
PPI in the design, management, conduct and dissemination of your project will help you carry out better research. Engage with PPI at every stage of the project. See also ‘Patient & Public Involvement' in the Applying for Funding section of the e-Pathway.
Translational Research Team (TRT)
Working in partnership with Research Support colleagues in RSSD, the TRT can advise you on the most appropriate funding scheme for your project and help you develop a competitive application. They can connect you with experts at key stages of your application, offer advice on your long-term research strategy, help you set milestones, create Gantt charts, and assist with writing intellectual property sections, in collaboration with UoB Enterprise.
Research Design Service
The NIHR Research Design Service offers professional specialist advice and support for the research design and methodology of projects planning a funding applications for submission to NIHR research programmes and national, peer-reviewed funding competitions for applied health or social care research.
Wellcome Trust Clinical Research Facility
The Clinical Research Facility Wellcome Trust Clinical Research Facility (uhb.nhs.uk) is a strategic alliance between University Hospitals Birmingham NHS Foundation Trust, the University of Birmingham and Birmingham Women’s and Children’s NHS Foundation Trust. The facility provides a regionally leading high-quality clinical environment where patients can take part in experimental and complex clinical research studies.
Clinical Trials Units
Clinical Trials Units provide an enabling and delivery platform especially for complex and/or high-risk trials. It is essential to seek input form colleagues as early as possible to ensure that you benefit from the expertise and resource are included in the grant application. The University has two UK Clinical Research Collaboration-registered Clinical Trials Units:
- The Birmingham Clinical Trials Unit (BCTU)
- The Cancer Research UK Clinical Trials Unit (CRCTU)
Please note that is an expected that regulated clinical trials or surgery trials (i.e. CTIMPs or, of medical devices) are managed by a clinical trials unit.
Where the project will be managed by a CTU, please refer to the CTU’s internal processes as steps may differ to this e-Pathway. See the overview for more information on the scope of the e-Pathway.
How do I decide on the project methodology?
The aim of your project will determine the methodology. One of the first things to consider is the classification of your project as audit, service evaluation or research. Health professionals are expected to undertake audit and service evaluation as part of quality assurance. These usually involve minimal additional risk, burden or intrusion for participants. Research is designed to generate new knowledge and might involve testing a new treatment or regimen. It is important to determine at an early stage whether a project is audit or research, and sometimes that is not as easy as it seems. The decision will determine the framework in which the project is undertaken. The Health Research Authority (HRA) has developed a decision tool to help decide whether your project is classified as research.
The HRA leaflet ‘Differentiating clinical audit, service evaluation, research and usual practice/surveillance work in public health’ provides further guidance.
Special project design needs
- The University publishes guidance on GDPR considerations.
- Consider the need for a Randomised Controlled Trials (RCT). RCTs offer a way in which it is possible to measure the effectiveness of a new intervention or treatment with a view to reducing bias and is often considered the 'gold standard’.
- Compliance with the UK Clinical Trial & Device Regulations. If you are planning an intervention you need to consider at an early stage what legislation might apply to you project. The Medicines and Healthcare products Regulatory Agency provides guidance to researchers. Please follow the MHRA algorithm to determine if your project is a Clinical Trial of an Investigational Medicinal Product (CTIMP).
- Are you planning to use data from NHS Digital, the body which collects data from GP practices to help support care and research?
- Consider whether any additional funding is required to archive the project once analysis is complete, see the UoB Archiving SOP (UoB-ARC-SOP-001) [Word - 198 KB] and the UoB Archiving Plan (UoB-ARC-QCD-001) [Word - 104 KB] for further details.
Draft your protocol to explore project feasibility
Draft your protocol to explore project feasibility
The research protocol is an essential part of a research project. Working with a template can help. Within the UoB clinical research QMS, there is a protocol template available to use for non-CTIMPs and Studies.
- Protocol Template for non-CTIMPs and Studies (UoB-ESD-QCD-004) [Word - 301 KB]
The UoB protocol templates have been developed in line with the HRA’s protocol template and guidance. It is recommended that the UoB protocol templates are used wherever possible as these also capture internal (UoB-specific) requirements.
To assist with the development of the project protocol there are also a protocol development tool available to use for non-CTIMPs and Studies. These contain more detailed guidance on what to include in the protocol.
Quick links
Your Feedback
e-Pathway index
e-Pathway index
The clinical research e-Pathway provides a roadmap to guide researchers during the lifetime of their research projects. Click on the links to take yourself to the stage that is of interest. You can also use the roadmap image on each page for navigation.
From Idea to Proposal (current page)
Applying for Funding
Project Setup
Green Light - Ready to Go?
Project Management
Project End
Please also refer to the Glossary of Terms for a complete list of the abbreviations and definitions used.
Need help with your project? See who can help.