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Clinical Research Facilities competition - Frequently Asked Questions

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Published: 01 June 2021

Version: 10 - 17 September 2021

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This document provides answers to frequently asked questions (FAQs) relating to the NIHR Clinical Research Facilities (CRFs) funding competition and is intended to supplement the CRF Application Guidance.

Please note, the deadline for submitting competition queries has now passed. However, queries regarding the submission of the application within RMS will still be permitted until call close and should be sent to ccf-infrastructure-team@nihr.ac.uk.  

FAQs added 1 June 2021

Scope of the award

1. How does NIHR define early translational and experimental medicine research and the type of work that can be included in a NIHR CRF application? 

The scope of early translational and experimental medicine within the NIHR spans the transition between the pre-clinical/clinical boundary, from ‘first-in-human’ studies through to the equivalent of Phase II clinical trials. This would include studies that are undertaken in human participants, or using human tissues that aim to identify mechanisms of pathophysiology or disease, demonstrate proof-of-concept, or the validity of new experimental designs and approaches. 

NIHR CRFs support the delivery of early translational and experimental medicine research studies, including early-phase clinical trials. They provide dedicated purpose-built facilities in the NHS specifically for the delivery of high-intensity research that requires dedicated space, facilities and specialist expertise. NIHR CRFs are a key part of the UK’s leading early-stage clinical research infrastructure and play an important role in making the country a global hub for life sciences and delivery of the government’s Life Sciences Industrial Strategy. They will also play a key role in realising the ambitions set out in the  vision for the future of UK clinical research delivery.

2. Are there any specific clinical and/or research areas that NIHR is highlighting for applicants to consider including in their proposed NIHR CRF?  

NIHR CRFs will support the delivery of early translational and experimental medicine studies across a range of, or, in a particular clinical/disease area.  Applications for NIHR CRF designation and funding may be made in any research area where the applying NHS organisation can demonstrate that they have appropriate facilities and expertise to support the delivery of the research studies. This should include the access to, and expertise of, research delivery staff.

While the guidance does not highlight any particular clinical/research areas, applicants will be expected to demonstrate the quality and breadth of high-quality early translational and experimental medicine research studies undertaken within the CRF.

The strategic plan should reflect 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.

Directors

3. Are there any limitations on the number of terms a NIHR CRF Director can serve? 

No.

4. Can NHS organisations include deputy or co-Director in their application?

Yes, it is permissible for NHS organisations to nominate two individuals to hold joint leadership of the proposed NIHR CRF as co-Directors. Each individual must hold a contract (or honorary contract) with the host organisation.

Study intensity

5. How do you calculate 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 view the study intensity tool training for clinical research page on the UKCRF Network website for further information on measuring study intensity and how to use the UKCRF Network Intensity Tool.

Patient visits

6. We are asked to provide a table detailing the number, and type, of patient visits to the CRF during 2019/20. This is the financial year before last. Is that correct?

Yes. We recognise that the financial year 2020/21 was unusual, with significant support provided to support the delivery of COVID-19 studies. As such we are requesting information from 2019/20 which is likely to be more representative of usual activity.

Overview of the facilities

7. There does not seem to be a requirement to submit a video to demonstrate our facility as per the last competition – is that true? Can we submit one anyway?

There is no requirement to submit a video. There is also no facility to submit a video. All description of facilities should be made via text, diagrams, floor plans and images as set out in the application guidance.

Collaborations

8. Are single NHS organisations encouraged to collaborate with additional organisations to form a Clinical Research Facility? 

NIHR CRF designation and funding will be awarded to a single NHS organisation. The designated NHS organisation may collaborate with other NHS organisations and may pass funding to them via an appropriate mechanism, such as a subcontract. Reasons for involving other NHS organisations in the work of the NIHR CRF will need to be justified in the application including evidence that these other organisations have appropriate facilities including access to appropriate staff.

Finance

9. How should NHS organisations that do not currently hold an NIHR CRF award phase their funding within their application?

The funding should be phased to provide time for the NHS organisations to set up their work programme and recruit to roles. Phasing should be realistic and, it is expected that during the first-year costs will be approximately 50% of forecast expenditure of a fully operational CRF.

FAQs added 9 July 2021

Directors

10. Is it possible to have a named Deputy Director in the bid?

There is no requirement to identify Deputy Directors within applications for NIHR CRF designation and funding. Following NIHR CRF designation, NHS Organisations may, if they wish, appoint Deputy Directors.

11. In the 'Leadership and Governance' Section is the expectation that applicants refer to, and outline the Director’s leadership in relation to what the CRF has achieved (under the leadership of the Director), or should this section include leadership and achievements of the Director at a personal level that are not necessarily and directly linked to the CRF?

Applicants should include information that they consider best supports their application for NIHR CRF funding. This should 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 for the research delivery workforce.

 12. How many co-directors are permitted?

It is permissible for NHS organisations to nominate two individuals to hold joint leadership of the proposed NIHR CRF as co-Directors. Each individual must hold a contract (or honorary contract) with the host organisation.

13. Are non-medical Directors acceptable?

Applying NHS Organisations should decide who they would like to appoint as Director, NIHR has not specified a requirement for a medical background. Applicants will be required to describe the leadership and expertise demonstrated by the proposed Director and their proposed contribution to the NIHR CRF.

Study Intensity

14. How should new applicants provide data on study intensity if they have not previously used the UKCRF Network Intensity Tool?

We would expect NHS Organisations who are applying for CRF designation to provide details of a study intensity for the studies that they cite in the application. The UKCRF Network Study Intensity Tool 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. The Study Intensity Tool, and training to support its use, is freely available via the UKCRF Network website. For NHS Organisations that don't currently have NIHR CRF designation, alternative measures for outlining study intensity can be provided and Committee members will take this into consideration when reviewing applications.

Strategic Plan

15. Section 5.1 of the application guidance asks for “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.” Is this question focusing on the processes in the CRF as to how EM/early phase studies are prioritised and allocated NIHR funded resources as part of its pipeline OR does the question relate to how CRFs will use other later-stage infrastructure (ARC, Trials unit, AHSC) to then continue and then implement/evaluates the subsequent research once the CRF study is completed?

This question refers to the processes within the proposed CRF to prioritise and allocate NIHR CRF funded resources to support the delivery of early translational and experimental medicine research studies.

16. Section 5.2 of the application guidance mentions “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.” Please can you provide more information as to the sorts of metrics we would be expected to measure performance against?

We expect CRFs to have operational processes and internal Key Performance Indicators in place to efficiently manage the allocation of resources. These should be described in Section 5.2 of the application form. It will be for the NHS Organisation to consider which metrics they intend to use to measure performance.

17. Does the 2,000 word count for the 'Strategic Plan' Section include the short, medium and long term objectives submitted in the table provided?

The 2000 word limit does not include text added to the table. Applicants are not restricted to a word limit for the short, medium and long term objectives however we would expect the objectives to be concise, with no more than 200-300 words describing how the proposed CRF will monitor and determine the successful completion of each objective.

Overview of the facilities

18. For data on staffing not all of the staff are currently funded by the infrastructure award. Is this information to provide an overall picture of staff in the facility and so we should include all staff?

Yes, all current staff within the facility should be included in Section 4.3 of the application (research facilities). This may include staff not funded by an NIHR infrastructure award. Staff for whom financial support is being requested as part of the NIHR CRF application should also be listed in the financial section of the application form.

19. The data on staffing in the research facilities section of the application asks for grades. Some of the current staff in the facility are on university pay scales, should we include the nearest pay scale in the application?

The expectation is that any newly established posts created with funding from this scheme will be employed by the NHS. However, where there is a local agreement for staff to be employed outside of the NHS, such as in a University, and where this does not attract additional costs over and above the normal costs of employment, this will be allowed (i.e. the cost of employer's contributions will be met, but the posts will not attract Full Economic Costs in the University).Where there are individuals who will be employed outside of the NHS, please indicate the equivalent / nearest NHS pay scale.

20. Can you advise how new facilities should approach the following questions:

  • 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.
  • A table detailing the type, and number, of patient visits to the CRF during 2019/20

It will be for the applying NHS Organisation to consider how best to complete the application.

21. Can we include paediatric cancer trials in our application?

Yes, paediatric cancer trials may be included in applications.

22. Should applications from new CRFs focus on their track record in a few specialties or include the potential for additional specialties if CRF funding was awarded?

It will be for the applying NHS Organisation to consider how best to complete the application

23. What type of certification would you expect to see for 'Evidence of any certification attained' in the 'Research Facilities' section?

This could be any certification that demonstrates the excellence of the research facility. This could include for example Good Clinical Practice certification or MHRA Phase I accreditation.

24. In the 'Research Facilities' Section, information on the duration of studies is requested - should this be "months so far to the date of the application" or the total predicted study duration?

Study duration should be the total expected duration of the study.

25. In the 'Research Facilities' Section applicants are requested to provide details of the current research delivery staff within the facility, including FTE. Do you require information on the FTE per study?

No, FTE per study is not required. This section should provide details of the FTE per post/individual.

26. What metric should we use to calculate the 'highest potential to translate into outputs likely to benefit patients and the public and/or the healthcare system'?

It is up to applicants to decide on how they plan to assess the potential to translate into outputs likely to benefit patients and the public and/or the healthcare system.

27. Can we include trial activity data for the year 2020/21 as well as 2019/20?

No. All applicants should include study data for the year 2019/20. Data submitted for other years (such as 2020/21) will not be considered by the Selection Committee.

28. In the 'Research Facilities' section where a list of up to 50 trials from the last 24 months is requested, should this include completed studies only, or can we include ongoing studies?

Applicants may include ongoing studies as well as those that have completed.

29. In the table of studies requested in the 'Research Facilities' Section we are requested to state whether the study was delivered to time and target (yes or no) but if the study has not yet completed this information will not be available. Therefore, should we only include completed studies?

Applicants should include studies that demonstrate the range of early translational and experimental medicine studies delivered by the CRF. If a study has not yet completed applicants may select 'No' and then in the free text box state the study status.

30. In the 'Research Facilities' Section, please clarify whether ‘inventory of the key equipment available to the facility’ should include equipment available for CRF trials that is not located in the CRF, but is located elsewhere in the Trust e.g. specialist imaging/scanning equipment, immunoassay analysers etc. that support CRF trial activity.

Applicants should include key equipment available to staff that supports the delivery of early translational and experimental medicine studies. This may include equipment not located within the CRF but available to CRF staff within to support the delivery of studies.

31. Please clarify the word count for the 'Research Facilities' question, does the 1000 word limit apply to the entire question?

The 1000 word limit refers to the first question in this section 'overview of the facilities’. Applicants will need to upload an attachment (maximum 12 pages) for the second part of the section and to complete three tables for the final part of this Section.

32. The application asks for the location of the CRF within the Trust and any associated campus. Should this be done using visuals, or is a narrative description acceptable?

It is up to applicants to decide how they would like to present the description and location of the facility.

Finance

33. Is it possible to export the finance form from the RMS so it can be worked on outside of the system?

No, this is not possible. Applicants must complete this section through the RMS.

34. Is there a maximum limit on the amount of funding that can be requested by a single applicant?

No.

Collaborations

35. Is there an expectation that CRFs will be able to demonstrate alignment with a BRC?

The NIHR CRF and BRC competitions are separate. NHS Organisations will not be expected to demonstrate alignment with a specific NIHR BRC but that they can support the delivery of high quality early translational and experimental medicine research. Applications will need to demonstrate the strength of strategic partnerships and collaborations including with other NIHR-funded research infrastructure (including NIHR BRCs and LCRNs) and other research funders including public funders, charities and industry.

Application Assessment

36. How will publications or other outputs from research conducted in the CRF (either the 50 cited studies or more generally) be included in the application. Will the impact of such publications form part of the assessment of the quality of research conducted?

NHS Organisations are not required to provide data on publications or other metrics beyond what is specifically requested in the application form.

37. Can you provide assurance on the rigour of the review process and composition of the independent committee?

Applications will be assessed in accordance with standard NIHR processes for awarding NIHR infrastructure funding. An Independent Selection Committee will make recommendations to the Department of Health and Social Care (DHSC) on the designation and funding of NIHR CRFs. The committee will review applications and make recommendations on the basis of the published selection criteria. The membership of the independent selection committee will be published after the closing date for receipt of applications has passed.

RMS

38. Is there a way to assign co-applicants on the application system so that colleagues can access and update relevant sections of the form?

Co-applicants added to the application will gain access to the entire application on the RMS and may edit any part of the form.

39. Does the proposed Director need to initiate the application in the RMS?

Yes, the individual starting the application will automatically be the person nominated as the Director. Subsequently, managers may be added as the administrative contact to gain access and editing rights to the application. If any problems are encountered using the RMS please contact us via email at: manager@ccfrms.org.uk or phone 0208 843 8050.

Other

40. Is there a restriction on the number of CRFs within a single region?

No.

FAQs added 16 July 2021

RMS

41. How do CRF Managers access the CRF application on the RMS?

The Lead Applicant may provide Administrative contact details in Section 10 of the application form. This contact will then have access to the application form.

Research Facilities

42. Is it permissible to provide additional information on the 50 studies within the 12 page upload?

It is up to the applying organisation to ensure studies chosen for the table demonstrate the capabilities of the CRF. The CRF's expertise should be highlighted in the Research Facilities section of the application.

43. What dates are included in the "24 month period" referred to in the table of 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 24 month period covers the 2019/20 and 2020/21 financial years (1 April 2019 to 31 March 2021).

44. In the "Research Facilities" section (4.2), is it possible to upload 12 pages in one document or must they be 12 separate pages?

Only one document with a maximum page count of 12 pages may be uploaded to the RMS.

45. Is it permissible to include photographs of patients and staff when demonstrating the facilities of the CRF?

You may include photographs of patients and staff however these must have been taken and used in accordance with local policies and legislation governing use of personal information.

FAQs added 27 July 2021

Strategic Plan

46. Can you confirm the word limit for the strategic plan now that the strategic plan and delivery plan sections have been combined?

The word limit for the strategic plan is 2000 words. This includes both section 6.1 and 6.2. 

Research Facilities

47. Are there categories to use when inserting information on 'profession' for staff or should we decide what information goes here?

It is up to the applicants to decide how to describe each individual's profession.

FAQs added 9 August 2021

Research Facilities

48. For the research facilities section of the application does the current research delivery staff within the CRF mean the clinical staff or the full team e.g. managers and reception teams?

The current research delivery staff should include all staff needed to deliver research studies within the facility. This may include those outside of the clinical staff such as managers and administrative staff.

49. Please confirm the time period for 1) the table of 50 studies that demonstrate the range of early translational and experimental medicine studies delivered by the CRF and 2) the table detailing the type of visit, and the number of patients who visited the CRF for that visit type, within the research facilities section of the application.

For the table of up to 50 studies the 24 month period covers the 2019/20 and 2020/21 financial years (1 April 2019 to 31 March 2021).

For the table listing the patient visits applicants should include data for the year 2019/20. Data submitted for other years (such as 2020/21) will not be considered by the Selection Committee.

Leadership and Governance

50. Please clarify whether the 1 page organogram required for this application should focus on the wider governance of the CRF (within the Trust) or the details of the CRF staffing including CRF functions and line management?

The 1 page organogram should focus on the governance arrangements for the CRF, including oversight of the CRF through external advisory boards and connections to the governance arrangements of the Trust.

Finance

51. Is there a cap on the proportion of CRF staff for which we can request funding, or a maximum funding amount in terms of percentage of staff salaries?

No, there is no cap on the proportion of CRF staff for which funding can be requested, or a limit on funding amount in terms of percentage of staff salaries. The independent selection committee will review the applications and make recommendations on designation and funding levels, considering that value for money is a key selection criteria

FAQs added 16 August 2021

Research Facilities

52. Please could you clarify if the funding amount reported in the table of 50 studies within the research facilities section is the total leveraged income for the Trust (including scans/pharmacy activity etc) or just funding leveraged by the CRF for participant research activities?

The funding reported should be the total income received by the Trust for the study.

Strategic Plan

53. Is there a limit on the number of SMART objectives we can have? Or a recommendation on the number of objectives that are short, medium or long-term?

We have not set any limits on the number of objectives,but would expect at least one short, one medium and one long term objective. It is for applicants to decide on the objectives that they think supports their application and that they expect to be able to evidence progress against.

Finance

54. Will NIHR be applying indexation at the award stage?

Applications should be costed at current (2021/22) prices, based on current salary scales and scale increments. Annual salary increments or other equivalent annual increases should be included in future years but not any other anticipated pay increases (e.g. nationally agreed pay awards). Do not include estimated uplift(s) for inflation. Should an award be made, annual uplifts may be provided, depending upon the budget available to NIHR.

FAQs added 20 August 2021

Research Facilities

55. The application states that the studies table should outline the ‘amount of funding awarded’ for the studies. Can you please confirm a) for non-commercial studies, does this refer to the overall grant award amount or the per patient/site fee? and b) for commercial studies, does this refer to the per patient fee as agreed in the Clinical Trial Agreement with the sponsor?

For both commercial and non-commercial studies 'the amount of funding awarded' refers to the overall income received by the Trust for conducting the study.

FAQs added 27 August 2021

Finance

56. Please can you confirm if the funds will be funded at 80% FEC?

The expectation is that any newly established posts created with funding from this scheme will be employed by the NHS. However, where there is a local agreement for staff to be employed outside of the NHS, such as in a University, and where this does not attract additional costs over and above the normal costs of employment, this will be allowed (i.e. the cost of employer's contributions will be met, but the posts will not attract Full Economic Costs in the University)

NIHR CRF awards will fund legitimate and reasonable, indirect costs for the NHS host organisation and other NHS collaborations. This will include the proportion of the costs of accommodation in the NHS, used for the NIHR CRFs work, and an appropriate proportion of HR, payroll, and finance costs.

57. Is it acceptable to include costs to increase bed numbers within the existing research facility?

No capital funding (for tangible fixed assets such as buildings and equipment costing over £5,000) will be available for NIHR CRFs through this funding competition. Applications should only include research that can be undertaken with the existing or planned facilities which already have confirmed funding.

58. Is it mandatory to complete the offline Excel finance form template available on the website?

No, the offline Excel template is available as a tool to assist proposed CRFs when building their applications. All finances must be completed on and submitted through the RMS system.

Research Facilities

59. In the Research Facilities section, which time period should be used to calculate the "average annual percentage occupancy of the CRF"?

The CRF should provide an average yearly occupancy and provide details of how this relates to the profile of early translational and experimental medicine research studies in terms of their intensity. The CRF should define the figures that they provide in this section.

60. In the study table, does the definition of "study duration" include followup activities for a study?

Study duration refers to the total time for which CRF support is provided to the study.

Strategic Plan

61. In the SMART objectives table, how should the CRF demonstrate that it will monitor progress and completion of its objectives?

It is up to the applicants to decide how best to evidence progress against the proposed objectives.

FAQs added 7 September 2021

Strategic Plan

62. In the SMART objectives table, does the 200-300 word limit include both the objective title and the details of how the proposed CRF will monitor and determine successful completion of the objective?

The limit of 200-300 words refers only to the details of how the proposed CRF will monitor and determine successful completion of the objective?. Please also see FAQ 63.

63 Whilst noting the answer to FAQ 53 stating that there is no set upper limit on the number of objectives, please could you provide further guidance on your expectations for this section?

Objectives should be SMART (Specific, Measurable, Achievable, Relevant and Time bound). We would expect at least one short, medium and long term objectives. Applicants are reminded that if successful they will need to evidence progress against each objective within the Annual Report submission to NIHR. We do not expect a granular list of all the individual activities or milestones that might be used internally by the CRF to monitor progress.

Research Facilities

64. Can we submit 360° photographs by way of a weblink?

Pictures must be included within the 12 page upload of the research facilities section. The upload must be a file of the following extension(s): doc, docx, pdf. Links to images on external sites are not permissible.

FAQs added 17 September 2021

Finance

65. What percentage should be applied to staff costs for the NHS pension?

Annual Costs of Staff Posts Applications should be costed at current (2021/22) prices, based on current salary scales and scale increments. This should include the staff salaries and relevant on-costs (i.e. pay increment dates, geographic weighting, superannuation, national insurance etc).

66. Can you please clarify the time period to base annual costs of staff posts?

Applications should be costed at current (2021/22) prices, based on current salary scales and scale increments. This refers to the current financial year (1 April 2021-31 March 2022).

Strategic Plan

67. Can you please clarify whether the number of objectives is capped?

While we have not set a maximum for the number of objectives an applicant can include, for technical reasons the RMS system requires us to set a limit. This has been set to 50 as it is not expected that applicants will exceed this.

68. Please could you clarify whether you are expecting a short, medium and long term target for each objective requested in the strategic plan section of the application form or should these objectives be linked to the strategic plan in its entirety?

The SMART objectives should be the overarching objectives that the CRF will seek to work towards in order to deliver their strategic plan.

Research Facilities

69. For the 12 page document in the Research Facilities section, is there a file size limit for this document (in Mb/Gb etc)?

The maximum upload is 40MB. We would recommend uploading large files as PDFs.

70. In the "Patient Visits" table of the application form, do applicants need to provide information for all of the studies conducted within 2019/20 or just the visits corresponding to the 50 studies selected? Do you require specific visit type detail for each study?

Applicants should provide figures for visits supported by all of the studies conducted in the FY 2019/20. Detail on a study by study basis is not necessary.

RMS

71. Is it permissible to include links to external websites within the application?

No. The Selection Committee will consider the information provided in the full application to make recommendations to DHSC on designation and funding. You should ensure your application is stand alone and contains sufficient detail to inform the Committee's review. The Committee will not refer to additional information published online in making their recommendations