e-Pathway: From Idea to Proposal

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. 

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.

• CRCT training and workshops
• Research integrity, ethics and governance training
• Library services research skills team
• National Institute for Health and Cancer Research
• West Midlands Research Training Collaborative (WMRTC)

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.

Fellowship and Grants Academy

 The Fellowship and Grants Academy aims to ensure that all early career researchers have access to a planned programme of support and training to help them on their journey to independent research. 

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.

The research protocol is an essential part of a research project. Working with a template can help. Within the UoB clinical research QMS, there are two protocol templates available to use depending on the project design.  

• Protocol Template for CTIMPs (UoB-CLN-PRO-QCD-002)*
• 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 two protocol development tools available to use depending on the project design. These contain more detailed guidance on what to include in the protocol. 

• Protocol development tool for CTIMPs (UoB-ESD-QCD-001) (currently under development – please see the Protocol template for CTIMPs (UoB-CLN-PRO-QCD-002)* that incorporate existing guidance 

•  Protocol Development Tool for non-CTIMPs & Studies (UoB-ESD-QCD-003) (Word - 320 KB)

* Please note that some of our documents are currently under review and link to this document has temporarily been removed. If you wish to access it, please contact the CRCT at crct@contacts.bham.ac.uk. 

The clinical research e-Pathway provides a roadmap to the various stages and sub-stages that a researcher may follow during the lifetime of their research project. Click on a link to take yourself to the stage that is of interest, or you can use the roadmap image on each page to navigate through the process.  

From Idea to Proposal (current page)

Applying for Funding

Project Setup

• Governance & Ethics
• Essential Documents
• Human Tissue & Data

Green Light - Ready to Go?

Project Management

• Quality & Oversight
• Adverse Events & Deviations
• Amendments

Project End

• Maximising Impact

Need help with your project? See the 'who can help?' section. 

For an overview of the e-Pathway, return to the homepage.