Clinical Research Facilities Competition 2021/22 - Application form guidance

This document provides guidance on completing an online application form in the NIHR Research Management System for applicants to the Clinical Research Facilities (CRFs) funding competition 2021/22.

The deadline for this call is 1pm on 29 September 2021

Any colleague(s) invited to participate on this bid will be required to log into Research Management System, access the application and actively select both the 'confirm' and 'approve' options. Please ensure that all applicants invited to collaborate on this application have confirmed their involvement and approval of the application form content before submission.

Signatures will be needed from the appropriate contact types in the ‘Declarations and Signatures’ section of the form. These will need to be obtained prior to submission. The signature boxes will only be accessible to those responsible for signing. 

Whilst confirming and approving an application can be done at any time during the submission of an application, it is strongly encouraged that this is done well in advance of the deadline.

The application details page will display details of the participants and roles. Please note application roles such as ‘co-applicant’ are used as standard contact types in the RMS, and should not be interpreted as the role the individual has in the bid. 

Applications will need to be approved by all listed participants. If a participant has multiple roles, these can be selected from the application details page and confirmations will be needed for all roles.  

Please note, participant details will only be visible in the application PDF once they have confirmed their participation. 

Section 1: Details of the Proposed CRF

Name of Proposed CRF

Please input the CRF Title. The title should consist of the word ‘NIHR’, the host NHS organisation name followed by the word ‘CRF’ (e.g., NIHR <NHS Organisation> CRF).

Details of the proposed CRF Director

Details for the Director will be pulled-through from the ‘Manage my details’ section of their portal account. Please ensure their account is updated prior to submission. The application form PDF will display these details.

Details of the proposed CRF Co-Director (Optional)

Details for the Co-Director will be pulled-through from the ‘Manage my details’ section of their portal account. Please ensure their account is updated prior to submission. The application form PDF will display these details. 

NOTE: It is optional to include a Co-Director, please leave this section blank if it is not relevant.

Host organisation

Please select the host NHS Organisation for the NIHR CRF award. 

Selecting an organisation confirms that appropriate support will be provided by the NHS organisation should the application be successful.

NOTE: If your organisation does not appear on this list, please contact us via email manager@ccfrms.org.uk or phone 0208 843 8050.

Details of the Host NHS Organisation Lead

Please provide details of the Host NHS Organisation Lead with authority to endorse the application for an NIHR CRF and confirm that appropriate support will be provided should the application be successful. 

Specified representatives of the organisation should fully endorse the application for an NIHR CRF award and confirm that appropriate support will be provided should the application for funding be successful.

Details for the Host NHS Organisation Lead will be pulled-through from the ‘Manage my details’ section of their portal account. Please ensure that this is updated prior to submission. The application form PDF will display these details.    

Senior Operational Manager

Please confirm there will be a Senior Operational Manager supporting the NIHR CRF.            

(Yes/No)

Any Other NHS organisations (optional)

Please list any additional NHS organisations that will be formally associated with the NIHR CRF.  

NOTE: If your organisation does not appear on this list, please contact us via email manager@ccfrms.org.uk or phone 0208 843 8050.

Total value requested 

This field will automatically populate once you have completed the budget section.

Section 2: Summary

Plain English Summary

In plain English, provide an overview of the NHS organisation’s proposal including background and key objectives of the CRF for supporting the delivery of early translational and experimental medicine research. The overview should explain the nature of the CRF and its aims. (Maximum 500 words)

Section 3: Leadership and Governance

Leadership and Expertise

3.1 Please describe the leadership and expertise demonstrated by the proposed Director and their proposed contribution to the NIHR CRF, this should include:

• The organisational leadership experience of the Director, including examples of leadership at a local, regional and/or national/international level;
• Evidence of their breadth of experience in the delivery of early translational and experimental medicine research studies;
• A statement highlighting the Director’s commitment to, and experience of, improving research culture, and equality, diversity and inclusivity in the research delivery workforce.

3.2 Please describe the management and governance arrangements for the facility, including how the CRF is embedded within the governance structure of the host NHS organisation; and the governance structures (including any external governance body(ies)) to be established for the proposed NIHR CRF. (Maximum 800 words)

Please upload an organogram to illustrate the structures outlined above. (Max 1 page)

NOTE: Uploads MUST be provided as a Word or PDF document or you may not be able to submit your application.

Please confirm that the proposed Director (or where relevant Co-Directors) of the NIHR CRF will have responsibility for, and authority over, the NIHR funding if awarded.

(Yes/No)

Section 4: Research Facilities

Overview of the Facilities

4.1 Please provide an overview of the facilities that are in place in the CRF and its NHS organisation, and any other NHS organisations that will be involved in providing the CRF (if applicable), to underpin the delivery of high quality early translational and experimental medicine research.

This should include details of outpatient and inpatient facilities, specialist equipment and laboratories to conduct a variety of research studies. (Maximum 1000 words)

4.2 Please upload details (up to 12 pages - including annexes) to illustrate the current CRF. To note: the RMS system will not allow applicants to upload more than 12 pages. The upload must outline the following information:

• A concise description of the facility, with supporting images that show:
• The location of the CRF within the Trust and any associated campus
• An annotated floor plan of the facility (please state the total area of the facility and its proximity and/or access to emergency care). Please link the annotations to photographs that illustrate the facilities available e.g.
• Patient rooms and the number of the beds available for high intensity studies,
• Prep rooms and /or sample handling areas
• Major key or specialist equipment within your research facility
• Other specialist areas of note. (Suggested 6 pages)
• A short description of the current research delivery workforce within the CRF indicating the overall level of skill and experience of the staff in delivering early translational and experimental medicine studies and how they are deployed.  (Suggested 1 page)
• An inventory of the key equipment available to the facility that will support the delivery of early translational and experimental medicine studies (Suggested 2 pages).
• The average annual percentage occupancy of the CRF, explaining how the occupancy of the CRF relates to the profile of early translational and experimental medicine research studies in terms of their intensity. (Suggested 1 page)
• Evidence of any certification attained.

4.3 Please complete the following tables to illustrate the current clinical research facilities.

 

Current research delivery staff

 

A table of current research delivery staff within the CRF. For each staff member please provide: 

• Title of post
• Profession
• Grade
• FTE (as a percentage out of 100)

Please enter each role individually. Do not batch staff roles together. FTE should be listed as a percentage out of 100. For example, if a staff member is employed full time it should be 100.

Studies that demonstrate the range of early translational and experimental medicine studies delivered by the CRF over the past 24 months

A table listing up to 50 studies that demonstrate the range of early translational and experimental medicine studies delivered by the CRF over the past 24 months. The table should outline the following:

• Study title
• Type of study
• Duration of the study
• The funder 
• The amount of funding awarded
• Study intensity (see FAQ for definition & tool)
• If study did not complete to time or to target please provide more information

Please enter each role individually. Do not batch staff roles together. FTE should be listed as a percentage out of 100. For example, if an staff member is employed full time it should be 100

Patient visits

A table detailing the type of visit and the number of patients who visited the CRF for that visit type during 2019/20.

Visit type should be selected from the following dropdown options:

• Outpatient
• Day patient
• Inpatient/overnight
• Outreach
• Telephone
• Laboratory

Study Intensity

The UKCRF Network Study Intensity Tool is designed to assist with workforce planning. It measures activity of nursing, laboratory, imaging and other research activity and calculates research specific time for each group in whole time equivalents (WTE) – helping define which staff groups will be active on the study. The tool measures the intensity and complexity of each individual study visit for the entire study and aids prospective planning during study set up. It can also assist in the costing of trials and grant bids.

Please visit the Study Intensity Tool Training for Clinical Research webpage for further information on measuring study intensity and how to use the UKCRF Network Intensity Tool.

(Select low, medium or high)

Confirmation that the study successfully recruited on time and to target

(Yes/No)

Section 5: Skills and workforce development

5.1 Please describe the CRF’s approach and future plans for- enhancing skills and further development of a highly skilled research delivery workforce for early translational and experimental medicine studies in the CRF; demonstrating a commitment to equality, diversity and inclusion.

Please indicate how the proposed NIHR CRF will:

• identify and deliver staff development opportunities for individuals who lead, design, support or deliver early translational and experimental medicine research at all levels; and
• provide training to enhance skills and workforce development in order to build further capacity and expertise within the NIHR CRF. (Maximum 1000 words)

NOTE: Additional images are not permitted in this section

Section 6: Strategic Plan

6.1 Please provide an overview of how the CRF intends to support the delivery of high quality early translational and experimental medicine research. 

This should include:

• The research or disease areas that will be supported by the proposed NIHR CRF. This should include a description of how the research portfolio will contribute to the health and wellbeing of patients and the public, and supports and promotes equality, diversity and inclusion
• An overview of how studies with the highest potential to translate into outputs likely to benefit patients and the public and/or the healthcare system will be prioritised and actively managed;

6.2 Please provide an overview of the management tools and systems in place to deliver the portfolio of early translational and experimental medicine research studies. This should include:

• a description of how the proposed NIHR CRF will fully utilise its clinical facilities to deliver early translational and experimental medicine research studies. This may include information on occupancy, visits, study intensity and risk;
• a description of how the CRF works to enhance the delivery of research. This should include a description of the quality management systems, policies and procedures in place to ensure compliance with Good Clinical Practice (where appropriate) and adherence to the UK Policy Framework for Health and Social Care Research and other relevant UK regulations; 
• a summary of the approach to increasing the diversity of participants in research studies and improving the research experience for participants;  
• an overview of the procedures in place to ensure the CRF will deliver studies to time and to target. This should include information on what metrics will be used to measure performance. (Maximum 2000 words)

6.3 Please complete the table to set out the specific (SMART) objectives that will be used to track the progress of the proposed NIHR CRF strategic and delivery plans. Please include details of how the proposed NIHR CRF will monitor and determine the successful completion of each objective.

• short term (1-2 years); 
• medium term (2-3 years); and 
• long term (4-5 years).

Table fields:

• Delivery
• Objective
• How the proposed NIHR CRF will monitor and determine the successful completion of each objective

Section 7: Approach to collaborative working

7.1a Please outline how the proposed NIHR CRF will collaborate with other research facilities in the NHS organisation, universities and with other NIHR research infrastructure both regionally and nationally e.g., Local Clinical Research Networks, other NIHR CRFs, NIHR Biomedical Research Centres, Experimental Cancer Medicine Centres. 

7.1b Please provide a description of how the NIHR CRF will contribute to and support the UKCRF Network.

7.2 Please describe the approach and strategy of the proposed NIHR CRF for working with industry, charities and other (non-NIHR) public funders of research. Please provide examples of key strategic partnerships already in place. (Maximum 750 words)

Section 8: Patient and Public involvement, Engagement and Participation

Please describe the CRFs approach to- and future plans for- Patient and Public Involvement, Engagement and Participation in the work of the CRF.

This section should consist of a summary of:

• The CRFs strategic objectives for Patient and Public Involvement, Engagement and Participation including attention to diversity and inclusion and reaching underserved communities.
• An outline of the lay involvement in the CRF governance structures.  
• Processes for measuring and evidencing the impact of the CRFs PPIE approach across the work of the CRF. (Maximum 750 words)

Section 9: Financial Plan and Justification of Resources

9.1 Please provide a financial plan for the funding being requested for the NIHR CRF  

Applicants will need to complete the ‘NIHR CRF Details’ tab and the financial plan. This will require:

• Detailed breakdowns of costs for staff posts and salaries, travel, subsistence, conference, equipment, consumables, PPIEP, dissemination, other direct costs, indirect costs and NHS support costs. 

Applicants should refer to the specific guidance provided within the form.

Finance guidance

Please refer to the associated finance guidance document to aid filling in this form. In addition, there are short videos to visually demonstrate how to complete this form.

If your finance query is not covered in the guidance then please direct your query to ccf-infrastructure-team@nihr.ac.uk

Staff Costs

Justification of Staff costs (Max 500 words)

Travel

Justification of Travel costs (Max 500 words)

Equipment

Justification of Equipment costs (Max 500 words)

Consumables

Justification of Consumable costs (Max 500 words)

Patient & Public Involvement, Engagement and Participation

Justification of PPIE costs (Max 500 words)

Biosample Storage

Justification of Biosample Storage costs (Max 500 words)

Other Direct Costs

Justification of Other Direct Costs (Max 500 words)

NHS Support Costs

Justification of NHS Support costs (Max 500 words)

Indirect Costs

Justification of Indirect costs (Max 500 words)

Totals

Table will automatically update when the above cost categories are completed.

9.2 Please provide a description of how these resources will be deployed to support the work of the proposed NIHR CRF, including:

• Justification for the resources requested;
• Please state the resources that you anticipate will be allocated to skills and workforce development;
• Please state the resources that you anticipate will be allocated to the PPIE activities of the CRF;
• The financial or other contribution from the NHS organisation or other relevant collaborators to the proposed NIHR CRF, noting that value for money will be a key aspect in the designation of the new round of NIHR CRFs. 

9.3 Please provide a statement on how activities would be prioritised in the event of the final award being decreased by the following levels of that applied for:

• -10%, or -50%. (Maximum 750 words)

Section 10: Administrative Contact Details

Please provide the details of the administrative contact, in the host NHS body or other provider of NHS services as a secondary point of contact for any queries relating to the application, should it be supported.

NOTE: This person will have access to the application form but does not need to be a co-applicant. 

Section 11: Research and Development office contact details

Please provide the contact details and job title of a person in the R&D office with whom we will liaise with to sign the contract should the application be successful.

NOTE: Please note this person does not need to be included as a co-applicant.

Section 12: Declaration and Signatures

COI declaration 

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

NOTE: Please declare any conflicts or potential conflicts of interest that you or your co-applicants may have, including any facts that, should they come to light at a future date, could lead to a perception of bias. Include any relevant personal, non-personal & commercial interest that could be perceived as a conflict of interest. Examples include (this list is not all encompassing) secondary employment, consultancy, financial or commercial gain (pensions, shareholdings, directorships, voting rights), honoraria, etc. In a case of commercial sector involvement with the application or the study, please state clearly the relationship to ownership of data, access to data, and membership of project oversight groups.

Authorised signatory of the proposed CRF Director(s)

In ticking this, you as the proposed Director(s) confirm that the information given on this form is complete and correct and that the NHS Organisation fully endorses the application for an NIHR Clinical Research Facility award and assert that appropriate support will be provided to the Unit should the application for funding be successful. You also confirm that the CRF will comply with all NIHR research governance initiatives, including use of model research agreements/contracts and compliance with the UK Policy Framework for Health and Social Care Research requirements.

Ticking this box constitutes an electronic signature of the directorial  role with regard to this application.

Chief Finance Officer of the Host NHS organisation

The Chief Finance Officer must approve the application and check the access controlled box below before the application can be submitted.

In ticking this, you as the Chief Finance Officer for the Host NHS Organisation confirm that you have checked the financial details of this application and that the named NHS Trust is prepared to carry out this research at the stated costs and to administer the award if made. You also confirm that the staff grades and salaries quoted are correct and in accordance with the normal practice of this organisation.  

Ticking this box constitutes an electronic signature of the supporting role with regard to this application.

Authorised signatory of the Host NHS organisation

This is the individual who can authorise this application on behalf of the Host NHS Organisation.

The authorised signatory must approve the application and check the access controlled box below before the application can be submitted.

Add Host NHS Organisation Approver:   

In ticking this, you as an authorised signatory for the Host NHS Organisation, confirm that the Trust fully endorses the application for an NIHR CRF award and assert that appropriate support will be provided to the CRF should the application for funding be successful. You also confirm that the NHS Organisation will comply with all NIHR research governance initiatives, including uptake use of model research agreements/contracts and compliance with the UK Policy Framework for Health and Social Care Research requirements.

I confirm that I have checked the financial details of this application and that this Organisation is prepared to carry out this research at the stated cost and to administer the awards if made. The staff salary quoted are correct and in accordance with the normal practice of this institution.

Ticking this box constitutes an electronic signature of the supporting role with regard to this application.

Section 13: Validation Summary

Applications are considered confidential by the NIHR and all reasonable steps are taken to ensure that this confidentiality is not breached. Further information and guidance can be found within the Confidentiality and Guidance Document. 

Please follow the next steps in order to complete your application submission process;

• Validate all mandatory/required fields listed below (that are required to be completed/amended) before submitting
• Check all co-applicants have completed their CV details as appropriate and review the PDF final version for any formatting issues
• Click 'Save and Close'
• Click the 'Submit' option (this must be completed by 1pm, 29 September 2021).

Please note that your submission will not be considered complete until all applicants have both confirmed and approved the application and the 'Submit' button becomes available and is then used.

You will receive an automated email containing the acknowledgment that we have received your application.

If you have any queries about the RMS and the application process please contact us via email at ccf-infrastructure-team@nihr.ac.uk or phone (020 8843 8050).