Clinical Study Grant preliminary application guidance

What's on this page

Use the links below to jump straight to the information you require. Please ensure you have read the information on this page before you complete a preliminary application form through the BHF Grants Management System.

• Before you apply
• When to submit your application
• How to apply

Before you apply

Applications for Clinical Study Grants are assessed in a two stage process: a preliminary application followed by a full application. Applicants should submit a preliminary Clinical Study Grant application at least 12 to 18 months before the expected start date of the study, and will need to receive BHF approval to submit a full application.

Please note: If your proposal has been endorsed by the GCRFF Multinational Clinical Trials Initiative, you do not need to submit a preliminary application for a Clinical Study Grant. Please contact the Clinical Studies Committee team to obtain a link to the full Clinical Study Grant application form.

Before completing an application, please read Clinical Study Grants, which lists the grant specifications and entry requirements, and includes videos with tips for preparing a high quality Clinical Study Grant application.

Please note that the principal investigator on a Clinical Study Grant should have a strong track record of trial management and management of high value grants, usually from BHF, and an internationally recognised research profile. Where appropriate and justified you can apply for the application to be led by co-Principal Investigators to accommodate a less experienced study lead.

We suggest you also read:

• How to apply
• BHF Standard Conditions of Grant
• Essential Information
• Costing a clinical study
• Policies for researchers conducting clinical trials

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When to submit your application

You should submit your preliminary Clinical Study Grant application at least 12 to 18 months before the expected start date of the study. Please also bear in mind the submission deadlines for full Clinical Study Grant applications when planning your preliminary submission.

We are unable to publish exact dates for preliminary application assessment meetings as they can change. However, we recommend that you use the submission dates below as a guide for when to submit a preliminary application to minimise the time between submission to decision. Typically, the time between the submission dates given below and receiving a decision will be approximately 5 weeks.   

• September 2025 - submit by 5pm Thursday 28th August 2025

• November 2025 - submit by 5pm Thursday 23rd October 2025

• February 2026 - submit by 5pm Thursday 5th February 2026

• May 2026 - submit by 5pm Thursday 23rd April 2026

• September 2026 - submit by 5pm Thursday 27th August 2026

• November 2026 - submit by 5pm Thursday 22nd October 2026

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How to apply

Please complete an online preliminary application form through our Grants Management System. You will be asked to attach a single Case for Support PDF document to the form, which should include all the points below. Please use all of the headings in the order specified.

Sections 1-15 together must not exceed 8 A4 sides, and sections 16-19 must not exceed 1 A4 side each.

Please use Arial font size 12 or the application will be rejected prior to formal consideration.

1. Project title.

2. Total amount of funding requested

3. Proposed start and end date and duration (in years and months).

4. Name, Department and Institute for each co-applicant.

5. Abstract of the proposed investigation (in 200 words or less).

6. Background to the study. Please include: 

• A description of the health problem being addressed.

• Why the research is important to people affected by, or at risk of, cardiovascular disease.

• What is already known about the topic (include how previous studies, meta-analyses or systematic reviews support the proposal).
  Further guidance: It is especially important to describe the available evidence for efficacy and safety of any proposed intervention. If there are known adverse effects leading to non adherence, this will need to be taken into consideration when calculating sample size.

• Why the study is needed now.

• What the study will add and how it is novel.

• How the study might impact on clinical practice.

7. Hypothesis to be tested and main research questions.

8. Study design. Summarise the proposed study design and justify each of its elements, as follows:

• UK/international trial. Please make it clear if the proposed trial is part of an international trial or, if UK led, if international sites are involved.

• Setting. Describe the clinical setting in which participants will be identified and invited to participate (e.g. general practice, hospital outpatients, ambulance service users). State whether the study will take place in multiple centres.

• Target population, including key inclusion/exclusion criteria and any relevant details about how that population will be selected (e.g. after a run-in period).

• Intervention and comparator. Include a brief description of experimental and control/comparator interventions. Note the dose and duration of the treatment period.

• Methods for allocation concealment (randomisation method).

• Blinding of treatments (where appropriate). State whether the trial will be placebo controlled. If not, explain how you will avoid the potential for bias in assessing outcomes (e.g. perhaps by using patient registries to identify outcomes).

• Primary and secondary outcome measures. State the main outcomes only and explain briefly why they were chosen. Explain how the outcomes will be reliably measured and at what timepoints. 

• Follow up. Provide details of the frequency and duration of follow up. Include whether consent will be obtained for longer follow up. 

• Methods for maintaining drug adherence, ensuring reliable capture of outcomes, and avoiding losses to follow up.

• Outline description of data analysis. Give a very brief summary of the method of analysis and explain why it was chosen, but note that a detailed analysis plan is not required.

• Sex/gender analysis. State if you are intending to perform a sex/gender stratified analysis and summarise briefly. If you are not planning to perform a sex/gender stratified analysis, justify why such an analysis is not required.  

9. Sample size calculation. Provide a proposed sample size, describing the event rate (which should be based on contemporary data) and explaining how it was estimated. Give a detailed justification for the event rate, estimated effect size, power and type 1 error rate.

10. Recruitment:

• State the expected recruitment timelines and provide a justification for your estimate. Explain briefly how recruitment will be organised (including the number of centres proposed to be involved in the trial) and whether there will be a vanguard phase (see evidence of feasibility below).

• Explain how you have assessed the feasibility of the study, giving details of any pilot work to establish trial methods and numbers of available participants, the existence of equipoise for the study question, the numbers of sites (including internationally, where relevant) that have given ‘in principle’ agreement to collaborate, and contemporary event rates.

• If international sites are involved, give details of the proposed UK and international recruitment targets. It should be clear what proportion of total participants are expected to be recruited from the UK.

• If recruitment has already commenced at some sites/locations, provide details of the latest recruitment figures for these sites versus recruitment targets.

• Under-served groups. Outline briefly how you plan to recruit a diverse group of participants that represents the population needing the health intervention, including how your recruitment and retention methods will engage with any relevant under-served groups (see NIHR guidance on defining and including under-served groups).

11. Evidence of feasibility:

Explain how you have assessed the feasibility of the study, giving details of any pilot work to establish trial methods and numbers of available participants, the existence of equipoise for the study question, the numbers of sites (including internationally, where relevant) that have given ‘in principle’ agreement to collaborate, and contemporary event rates.

For UK wide studies it is important to provide evidence that the study is addressing a clinical question that is considered a priority by the relevant clinical community. We strongly encourage applicants to engage with the BHF Clinical Research Collaborative who may be able to help in this regard.

Further guidance: Since many trials fail due to difficulties in recruitment, it is important to provide substantive evidence of feasibility at the outline stage. This will preferably include pilot data of feasibility. 

If there are any concerns about deliverability, the BHF strongly encourages applicants to consider conducting a pilot study either before applying for funding for a definitive trial (through a stand-alone application), or as a 'vanguard' phase in an application for a larger trial, with full funding contingent on satisfactory milestones being reached within the vanguard phase. 

12. Vanguard phase. BHF would usually expect an application for a large, multicentre clinical trial to include a vanguard phase. If you are planning a vanguard phase to establish deliverability of the trial, provide brief details. If you are not planning a vanguard phase, justify why not. 

13. Patient and public involvement. Describe briefly how patient and public involvement (PPI) will/has informed and/or influenced the development of the study. Read more about PPI in research.

14. Study management. Explain briefly how the study will be managed and the name of the registered clinical trials unit managing the study. If the study includes an international collaboration, please provide an overview of arrangements for management of the study across the collaborating countries.

15. Project timetable. Outline the main stages of the proposed study and the expected duration of each.

16. Summary of costs. Provide a categorised summary of total expected costs and anticipated contribution from NIHR CRN, its equivalent in the devolved nations, or any other funder (e.g. drug company). If other funders are involved, provide details of the status of funding applications and amount requested from each funder.

• See Costing a Clinical Study for further information about how to attribute the costs of a clinical study.

• Please find an example table outlining the types of cost you should potentially be considering for your study and the level of detail you should provide.

• At this stage, you can provide approximate figures for these costs.

17. Flowchart. Provide a flow diagram illustrating the study design and the flow of participants.

• The flowchart should be in a PDF and not PowerPoint.

• Key information to convey includes the timing of all study activity, starting from initial eligibility, screening, randomisation and each study visit through to long term follow up. 

• Complex interventions and controls, and the procedures and assessments performed at each visit should be described as accurately and fully as possible within the diagram.

• If proposing a randomised controlled trial, please refer to the CONSORT statement and website for additional guidance.

18. Key references. List a maximum of 10 key relevant references

19. Commercial collaborators. Give the name and type of contribution from any commercial collaborator (e.g. drug company) if relevant. See BHF Commercial Collaborations Guidelines for further information.

20. Grants and publications. List relevant grants held and publications for the principal investigator (a maximum of six grants and six publications).

• For grants, include the date of the grant award, funding body, reference number, title, amount awarded and the role of the applicant (e.g. principal applicant or co-applicant)

• Include a sentence outlining the applicant's contribution to each of the grants and publications.

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