This site is optimised for modern browsers. For the best experience, please use Google Chrome, Mozilla Firefox, or Microsoft Edge.

21/61 UK-wide antiviral clinical trial platform in non-hospitalised patients - guidance notes

Contents

Application summary information

Please carefully read the commissioning brief as this sets out the evidence that research teams will need to provide to be considered for this funding call. Teams that do not provide clear evidence that they meet the criteria given in the brief will not be shortlisted.

These guidance notes have been written specifically for this call as you will need to provide different information to that provided in a standard NIHR call. Please read this guidance carefully and follow it when completing each field of the form.

Host organisation

Please give details of the organisation that will be the contractor if the project is funded.

Please note that we expect the CI’s host organisation (substantive employer) to act as the contractor

Please also bear in mind that:

  • Thought must be given to the most appropriate institution to act as the contractor as part of the application process, as changes are unlikely to be agreed once a funding decision has been made.
  • The contractor is expected to respond to annual financial reconciliation exercises, provide the final financial reconciliation statement for the project and to provide ad hoc requests for financial information during the lifetime of the project. In the unlikely event that a request is made for the contractor to differ from the CI’s host institution, the suggested contractor must be able to fulfil these expectations and to do so in the usual timeframes.
  • In the same way, the contractor is expected to respond to any queries relating to Intellectual Property, commercialisation and benefit realisation.

If you have any queries, please contact nets-finance@nihr.ac.uk before submitting your application.

Research title (300 characters)

Please use the title of the brief.

Research type

This will be primary research.

Proposed start date, end date and project duration

This contract will be initially for 24 months. In the start date please provide details of when you could start the study set up (this must be the first of the month) and in the duration state 24 months. There will be a break point at 12 months at which point the ATF will review the continuing requirement for the platform.

Total (stage 2) research costs

Automatically populated from detailed budget section.

Total (stage 2) NHS Support and Treatment costs or external (not NHS) intervention costs

Automatically populated from detailed budget section.

Administrative contact details

If you wish our main contact to be someone other than the Lead Applicant please choose “no” and provide administrative contact details.

Lead, joint lead and co-applicants details/CV

Complete your name, contact details and other requested information.

ORCiD ID

Please note: You are required to obtain a free unique ORCiD ID number and update your MIS user profile with this before you can submit your application. By clicking the link ‘View ORCiD record’ you will be taken to the ORCiD website where you will need to register or sign in. Once logged in to ORCiD and following acceptance of T&Cs, you will be returned to the MIS and the profile field for your ORCiD number will automatically be populated. You will only have to do this once. For a Stage 2 application this is a mandatory requirement.

Specify your (lead applicant) role in this research (limit: 200 characters)

Explain in addition to your role as lead applicant, the role that you will be undertaking in the research, e.g. co-ordination and project management, analysis, methodological input etc.

Lead Applicant’s % FTE Commitment

Commitment: This refers to the percentage of your time that you will commit to this project.

Research background – lead, joint lead and co-applicants

Publication record (limit 10,000 characters)

Provide details of a maximum of six of your most recent / relevant publications (in the last 10 years) relevant to this application (using Vancouver or Harvard citation format) listed one after another with a blank line between each one. Please use DOI reference numbers if needed.

Research grants held (limit 10,000 characters)

This should include research grants held (as a named applicant) currently or in the last five years – as well as any additional previous grants, relevant to this application. Please include who the grant is with and the amount of each grant. If no grants are held, please enter N/A (as this is a mandatory field). For each entry you should state the registration number and name of registry and the DOI of the main related publication. Where the study is still ongoing or final results have not yet been published, please provide an estimated publication date. This is in line with the NIHR policy on clinical trial registration and disclosure of results.

History of application - Has this application been previously submitted to this or any other funding body? (completed by lead applicant only)

Select ‘Yes’ or ‘No’ from the drop-down box to indicate whether this or a similar application has previously been submitted to this or any other funding body.

Applications submitted to other NIHR programmes (completed by lead applicant only)

Where this application or a similar one has been submitted to this or another NIHR programme or elsewhere please click the ‘Add’ button and complete the necessary information.

The research team – joint lead applicant/co-applicants

Joint lead applicant/co-applicant

Please give details of any joint lead applicant and co-applicants

Note: For application/contracting purposes the joint lead applicant will be regarded as a co-applicant.

Please click the ‘Add’ button and select the joint lead applicant role drop down option and enter their details (if applicable).

Relevant expertise and experience of joint lead applicant (limit: 1500 characters)

Please summarise the proposed joint lead applicant’s relevant expertise and track record in applied health or social care research, in terms of skills and experience, previous publications, grant funding and impact on service provision.

Co-applicants/co-applicants – patient and public involvement (PPI)

Add details of all co-applicants (including Joint Lead Applicant if applicable) and their specific role in the project. The number of co-applicants is calculated automatically. Do not include collaborators, who should be mentioned (if necessary) in the Detailed Research Plan section/upload of the on-line application form.

Co-applicants are those individuals with responsibility for the day to day management and delivery of the project. Co-applicants, including public co-applicants, are considered part of the project team and are expected to share responsibility for its successful delivery. In contrast, collaborators normally provide specific expertise on particular aspects of the project but who do not share in the responsibility for the delivery of the project.

See our guidance for how co-applicants complete their sections.

Your application must be submitted, including the co-applicant’s section by the closing date and time for the call. Please note that any out of offices or undeliverable messages from the co-applicant’s mailbox will be received by an unmonitored email account at NETSCC.

Other supporting roles – signatories (electronic)

Please leave blank. This information is not required at this stage of the application.

Scientific abstract

Please leave this section blank.

Details of your proposed study and your expertise to conduct it should be provided in the Detailed Research Plan upload.

Plain English summary

The importance of a plain English summary (limit 3,500 characters)

A plain English summary is a clear explanation of your research.

If your application for funding is successful, the summary will be used on National Institute for Health Research (NIHR) and other websites.

If it is felt that your plain English summary is not clear and of a good quality, then you may be required to amend it prior to final funding approval.

It is helpful to involve patients / carers / service users / practitioners and members of the public in developing a plain English summary.

Content

When writing your summary consider including the following information where appropriate:

  • aim(s) of the research
  • background to the research
  • design and methods used
  • patient and public involvement
  • dissemination

Further guidance on writing in plain English is available online at NIHR Make it clear.

Changes from first stage

Please leave blank. This information is not relevant to this application.

Patient and public involvement (PPI)

PPI approach, management and support

Explain why your approach to patient and public involvement is appropriate for this proposal. In your description you will need to say who will be involved and why.

  • Please use this opportunity to describe how you plan to manage and coordinate the patient and public involvement activities in your project.
  • Describe how you will support and enable patients/service users, carers, the public and members of relevant communities to contribute to your research.

You can find further resources to support the design of your PPI here, NIHR PPI resources for applicants.

PPI lead

There should be a named person with appropriate skills and experience who is responsible for leading the PPI element within the project. This role should be an adequately costed and resourced research team member who is able to manage the PPI plans and related activities. For examples of the activities a PPI lead might undertake please see NIHR: Role of PPI Lead in a Research Team.

Justification of costs (limit 8,000 characters)

  • Please provide a breakdown of research costs associated with undertaking the research and provide justification for the resources requested. This should include the following costs: staff costs, travel and subsistence, dissemination costs, equipment (including lease versus purchase costs), consumables, patient and public involvement (PPI) and any other direct costs. For help with estimating PPI costs please see the NIHR Payments Guidance for researchers and professionals.

  • You should describe the value for money of the conduct of the proposed research.

Higher Education Institutions (HEIs) should determine the Full Economic Cost (FEC) of their research. For HEIs, up to 80% of FEC will be paid. For applications where the contractor is an NHS body or provider of NHS services in England, up to 100% of direct costs will be paid.

Detailed budget breakdown

To enable rapid contracting of the funded study please provide as much financial detail as possible in this application. We understand that this is challenging given the timescale of this call but please provide these as accurately as possible. If recommended for funding applicants are likely to be asked to revise costs prior to contracting and at this point there will be opportunity to make minor amendments to costs.

As the interventions to be tested are not know yet please leave any intervention related costs blank.

General information

  • Costs must be provided at current prices. An adjustment for inflation will be made annually thereafter at rates set by the Department of Health. Whilst allowances for incremental increases should be included on the form, nationally or locally agreed pay increases should be excluded.
  • Years should be calculated starting from the anticipated start date of the proposed research. For example, if your research is expected to start on 01 June 2020 then its second year starts 01 June 2021.
  • Further itemisation of costs and methods of calculation may be requested to support the application at a later date.
  • Payments will be made to the contracted organisation only and the contracted organisation will be responsible for passing on any money due to their partner organisation(s).
  • Appropriate sub-contracts must be put in place for any element of the research which is to be paid to another organisation.
  • As the interventions to be tested are not currently known applicants should not include any intervention costs.

Costs for un-named co-applicants

  • If you need to provide costs for more than one unnamed individual it is important to name them as ‘TBA 1’, ‘TBA 2’ etc. not just ‘TBA’, otherwise their costs will not appear in the PDF version of the form.

Information on different types of organisations

Higher Education Institutions (HEIs)

  • Higher Education Institutions (HEIs) should determine the Full Economic Cost (FEC) of their research using the Transparent Approach to Costing (TRAC) methodology. For HEIs, up to 80% of FEC will be paid, provided that TRAC methodology has been used.

NHS bodies and other providers of NHS services in England

  • For applications where the contractor is an NHS body or provider of NHS services in England, up to 100% of direct costs will be paid.

Other partner organisations

  • If you are a commercial organisation/consultancy, please fill in direct costs and commercial indirect costs. Indirect costs should be charged in proportion to the amount of research staff effort requested on the funding application form. Up to 100% of costs will be paid.
  • If you are an ‘other partner’ organisation (e.g. charity or NGO), please fill in direct costs and other partner organisations indirect costs. Indirect costs should be charged in proportion to the amount of research staff effort requested on the funding application form. Up to 100% of costs will be paid.

Direct costs

These are costs that are specific to the research, which will be charged as the amount actually spent and can be supported by an audit record. They should comprise:

  1. posts and salaries summary. This section presents an overview of salary and associated on-costs for the applicant(s) contributing to the research, including normal salary increments broken down individually.

    Please include all members of staff working on the research by clicking ‘add a new staff member’ or editing a current one. If there are any applicant(s) whose costs are not being claimed you should still include their details within this section, but don’t include any actual costs. Where applicants are already in receipt of NIHR funding for any part of their salaries (e.g. NIHR Fellowships), these should not be additionally charged to the project. Where applicants are already receiving salaries funded by NIHR, these should be declared in the application - application - please note that the NIHR will not fund more than 100% of an applicant’s time across multiple NIHR projects/awards and this fact will be checked prior to contracting. If you are unsure about this requirement or have any questions please contact the appropriate NIHR research funding programme.

    The Apprenticeship Levy can be included in the salary costs from 1 April 2017 where relevant.

  2. Apply to years. This section specifies the annual costs of each applicant contributing to the research. You should now allocate the individual staff member costs to each year of the research, allowing for increments. Use current rates of pay, and build in any known annual increments (again at current rates). You will not be able to claim for pay awards retrospectively, once your research is underway.

    Please note the ‘Total Salary’ column figures need to be calculated using the current annual costs, %FTE and number of months. If the research lasts for several years and an individual’s involvement varies over the course, it may be necessary to explain fully in the justification of costs section the % FTE and months per year for an individual staff member.

    It is important to double check that the % FTE, total months and yearly costs information are consistent with the information presented in ‘Details of Posts and Salaries’ (‘Details of Posts and Salaries’ should show the full current staff costs independent of % FTE etc., whereas the yearly costs in ‘Annual Costs of Posts’ depend on % FTE etc.).

    Please ensure that you check the ‘Type of Cost’ box which describes the employing organisation for a member of staff as this impacts on the level of funding provided. Staff employed by a Higher Education Institution (HEI) are funded at 80% of cost and staff employed by NHS, commercial or other partner organisation at up to 100% of cost.

    Please note that this section also includes ‘Shared Staff Costs’ which is located under directly allocated costs in some other funders’ applications. These are costs of an institution’s research resources which can be charged to the research on the basis of estimated use, rather than actual costs. These may include: IT technicians, laboratory staff, and costs of pooled staff efforts. HEI indirect costs cannot be claimed on these shared costs.

  3. Travel, subsistence and dissemination costs. This section includes journey costs, subsistence and dissemination costs, including conference fees and open access publication costs. Where applicable, you will need to include the travel and subsistence costs of your Project Advisory Group, Steering Committee and/or Data Monitoring & Ethics Committee. Travel and subsistence costs relating to dissemination should also be included here, as should costs relating to overseas travel.

    Journey costs

Enter the total cost of transport for all journeys for destination/purpose. If travel is by car, apply your institution’s mileage rates (however this should not exceed HMRC approved mileage allowance payments, which is 45p per mile for the first 10,000 miles and 25p thereafter).

Travel by the most economic means possible is encouraged. NIHR programmes do not usually fund first class travel.

Subsistence

Subsistence covers accommodation (if necessary) and meals associated with the travel, excluding any alcoholic beverages.

Dissemination costs

Conferences

Where national or international conference costs are included, a statement naming the conference or purpose of travel and the benefit to the research must also be made; failure to adequately justify your attendance at a conference, will mean the programme will not fund this cost.

For research of up to five years, the programme will usually fund up to a maximum of two individuals to attend one international conference, or one individual to attend two international conferences. For research beyond five years, the programme will usually fund up to a maximum of two international conference attendances per five year or part of five year research period.

Open Access costs

During the course of your project and throughout review and publishing phase you may choose to submit an article based on your research to an Open Access publication. Depending on the publication you may be subject to an article processing charge (APC). APC rates vary but are usually within the range of £300 and £3000. Open Access publications usually list their APC rates on their websites.

Where possible you should include an estimate for any APC in your funding application, since NIHR expects that APCs will be covered by the funding award.

Other dissemination costs

Any large costs should be further detailed with a breakdown of constituent parts or a timescale profile of the costs. Meetings to share best practice, training events and events to disseminate research findings must be run at the lowest possible cost with minimal catering. ‘Conferences’ which are described as such are not eligible for funding.

  1. Equipment. Essential items of equipment plus maintenance and related costs not included as part of estates should be input in this section. These can be lease or purchase costs. The purchase cost of pieces of equipment, valued up to £5,000 excluding VAT, will be considered.

    Pieces of equipment costing more than £5,000 to purchase will usually need to be leased. Where applicants are leasing equipment with a purchase price of more than £5,000, a comparison of leasing verses purchasing costs must be provided in the ‘Justification of Costs’ section.

    Items of equipment valued at £250 or more must be itemised separately; however, grouping same type equipment is permitted. Costs of computers are normally restricted to a maximum of £1,000 each to include VAT and any associated software. A statement of justification must be included, in the relevant ‘Justification of Costs’ section for any purchase above this limit.

    Equipment must exclude VAT, but if your organisation is unable to reclaim/recover the VAT on a piece of equipment, you should check the box ‘VAT cannot be reclaimed’.

    You will need to seek expert advice from the organisation purchasing the equipment regarding its VAT status. If you check the ‘VAT cannot be reclaimed’ column, VAT at 20% will automatically be calculated into the overall cost of that item.

  2. Consumables. This section includes non-reusable items specific to the research. Please itemise and describe the requirements fully (e.g. postage, stationery, photocopying). These items should be research specific, not just general office costs which should be covered by indirect costs.

  3. Patient and Public Involvement. Please itemise and describe fully the costs associated with Patient and Public Involvement. These are likely to include individual travel, out of pocket expenses, payment for time and any relevant training and support costs. Costs related to study participants should not be itemised here.

    If voluntary, charity of community groups are supporting the research via activities such as facilitating contact with potential participants, contracting research activities or providing advice, an adequate budget must be included to compensate for their time and resources.

  4. Other direct costs. These are costs, not identified elsewhere, that are specifically attributed to the research. For example, costs associated with the use of research facilities, external consultancy costs, costs associated with inclusivity (which may include, but are not limited to justified translation of research participant material into other relevant languages), computer licensing, recruitment and advertising costs. Please note that for organisations claiming indirect/overhead costs, costs such as recruitment of staff, and general training (e.g. in common IT packages) are costs that should be covered by the indirect costs element of the award being sought and should not appear in this section.

    If external consultancy costs are included in this section they must be fully justified in the ‘Justification of Costs’ section. Please specify the hourly rate and the number of hours and note that consultants must not be people who are already employed by the applicant’s institution. If they are, any costs should be entered as direct costs in the ‘Details of Posts and Salaries’ and ‘Annual Costs of Posts’ sections.

Indirect Costs/Overheads

Indirect costs will be charged in proportion to the amount of research staff effort requested on the award. Commercial/Other Partner Organisations should calculate them, using their own cost rates.

They comprise:

  • General office and basic laboratory consumables
  • Premises costs
  • Library services/learning resources
  • Typing/secretarial
  • Finance, personnel, public relations and departmental services
  • Usage costs of major research facilities
  • Central and distributed computing
  • Charge out rates for shared equipment
  • Cost of capital employed

NHS bodies or other providers of NHS services indirect costs

NHS indirect costs cannot be claimed through NIHR/DH programme funding. NHS Bodies or other providers of NHS services have been allocated NIHR Research Capability Funding (RCF) to contribute to the cost of hosting NIHR/DH-supported research.

HEI indirect costs

Total HEI indirect costs must be fully justified. HEIs are permitted to claim estate and other indirect costs. These costs are calculated on the basis of TRAC methodology. Proposals from other types of institutions/organisations should leave this section blank.

HEI indirect costs are based on the number of full-time equivalent research staff working on the research and the indirect/estates charges set by an institution. Please note HEI indirect costs cannot be claimed on shared staff costs. Where staff from more than one HEI are working on the research there may be different indirect/estates charges for each one. Please list each institution on a separate line.

The applicant(s) should consult their HEI Finance Departments for the appropriate figures to include in the estate charges and other indirect cost sections.

Commercial/other partner organisation indirect costs

Commercial/other partner organisations can claim indirect costs which are the costs of resources used by the research that are shared by other activities. Please seek advice from your finance department about the appropriate cost for this section.

Total commercial/other partner organisation indirect costs must be fully justified.

NHS support and treatment costs (incl. excess treatment costs/savings)

The finance section includes a section that asks researchers to provide an estimate of the patient care costs associated with the research (if applicable). An explanation of why these costs are being incurred and the basis on which the estimations have been made should be fully detailed under the relevant ‘Justification of Costs’ section.

The funding committee will take NHS Support and Treatment Costs into account when considering the value for money of the research. It is important that you consider these costs and discuss them with the NHS bodies or providers of NHS services involved in order to avoid any delay in commencing the research.

  1. NHS support costs

    These are the additional patient care costs associated with the research, which would end once the R&D activity in question has stopped, even if the patient care service involved continues to be provided. These might cover items such as extra patient tests, extra in-patient days and extra nursing attention. Researchers should contact their local NHS R&D Department initially and, if they are unable to help directly or if there is no local NHS R&D Department, contact the Local Clinical Research Network Senior Manager for advice on NHS Support Costs.

  2.  NHS treatment costs

    Please read the guidance on the funding of excess treatment costs prior to completing your application.

    These are the patient care costs that would continue to be incurred if the patient care service in question continued to be provided after the R&D activity has stopped. In determining NHS Treatment costs you must assume that the patient care service being assessed will continue even though there may be no plans for it to do so. Where patient care is being provided which differs from the normal, standard, treatment for that condition (either an experimental treatment or a service in a different location from where it would normally be given), the difference between the total Treatment Costs and the costs of the “usual standard care" (if any) constitutes Excess Treatment Cost/Saving, but is nonetheless part of the Treatment Cost, not an NHS Support or Research Cost. These costs should be determined in conjunction with your NHS body or provider of NHS services and their commissioners.

    Please note if the patient care intervention under investigation is in addition to usual care there is no need to complete the ‘Usual Treatment Costs’ section however this will need to be justified in the relevant ‘Justification of Costs’ section. If the patient care intervention under investigation either wholly or partially replaces usual care, the ‘Usual Treatment Costs’ section must be completed.

    For further information, please see:

    Attributing the costs of health and social care research and development (AcoRD)

Management and governance

Please answer the three questions.

Uploads

Please only upload the detailed research plan and any references or timetable. Any additional documents will not be considered by the funding committee during its review.

Attachment 1: detailed research plan

Please use the Detailed Research Plan to succinctly and clearly provide clinical, scientific and methodological detail about your study and explain how your platform study will be set up and how it will be able to conduct timely and effective evaluations of candidate treatments.

Please also explain provide evidence that your team meets the requirements set out in the brief.

Headings

  1. Evidence that your team has expertise in the following areas:
    1. Delivering multi-centre interventional studies in community settings in the UK, including adaptive platform studies
    2. Delivering a large multi-centre Clinical Trial of an Investigational Medicinal Product (CTIMP) in the UK
    3. Ability to perform inclusive studies that identify and recruit from under-served populations and populations where outcomes of COVID-19 have been poor to date
    4. Experience in establishing and coordinating data input from a wide variety of sites
    5. Suitably skilled virology expertise within the team or consortium
    6. Track record in rapidly training sites to ensure robust completion of electronic case forms and data required to measure primary and secondary outcomes and pharmacovigilance data
  2. Explain your proposed study design, methodology, aims and proposed Primary and secondary outcomes.
    1. Inclusion and Exclusion Criteria: Explain what your inclusion criteria will be and how your study will be truly inclusive. Explain how you will minimise exclusion criteria to ensure maximum participation required in a pragmatic study. Specify any exclusion criteria that will be required
  3. Explain how PPI will be involved in this project
  4. Timeline
    1. Provide a timeline for rapidly setting up the platform and starting recruitment to the first study arms.
    2. Provide a timeline and process for rapidly adding new intervention arms to the study.

Format

  • have a font size of 11 Arial
  • not exceed 10 (A4) pages
  • have a header containing your allocated project reference number if known (e.g. NIHR12345)
  • have a footer showing your page numbersbe converted to a .PDF version before uploading

Guidance for applicants on equality, diversity and inclusion for study participants

Every person eligible to take part in research should be offered the same opportunity of taking part in that research regardless of:

  • Geographical location
  • Age
  • Disability
  • Gender reassignment
  • Marriage and civil partnership
  • Pregnancy and maternity
  • Ethnicity - link (for example) to the toolkit for increasing participation of BAME groups in health and care research
  • Religion or belief
  • Sex
  • Sexual orientation
  • Socioeconomic status
  • Access to health or social care

All NIHR applications are expected to include information about how this data will be collected. Applicants should demonstrate how these factors have been considered and addressed in their proposal, including steps taken to ensure the research sample is representative of the population the study is targeted at. Applicants need to explain who they are planning to recruit to ensure inclusivity of study participants and justify and explain any exclusions, for example by completing an Equality Impact Assessment. Additionally, applicants should demonstrate that all potential recruiting locations have been considered and the research is deliverable to those areas.

Helpful links:
Involve: diversity and inclusion
NIHR: equality, diversity and inclusion

Attachment 2: references

Please list the main references using Vancouver or Harvard referencing conventions.

Acknowledge, review and submit

Conflict checks (limit 2,000 characters)

Please declare any conflicts or potential conflicts of interest that you or your co-applicants may have in undertaking this research, including any relevant, non-personal and commercial interest that could be perceived as a conflict of interest.

Agreement to terms and conditions

I have read and understood the terms on which I have been nominated as Chief Investigator for this proposal along with the associated documentation and accept this role.
A list of terms and conditions can be found here (page 5).

Equality and diversity monitoring information

NIHR is committed to promoting equality, diversity and inclusion in research and asks applicants to provide Equality and Diversity Monitoring Information (age, sex, ethnicity and race, and disability). By answering these Equality and Diversity Monitoring Information questions, you will help us to better understand the different groups of people that apply to us for funding and their experiences of the funding process – particularly the groups protected by UK equality legislation. Although it is mandatory to answer these questions, it is possible to select “prefer not to say” as a response. However, the more information you provide, the more effective our monitoring will be. This information will not be used to make decisions about funding.

Checklist of information to include when submitting a NIHR research application

Please ignore this section. This information is not relevant to applications to this call. Leaving it blank will not affect your ability to submit your application