This document provides the answers to Frequently Asked Questions (FAQs) relating to the National Institute for Health Research (NIHR) Commercial Research Delivery Centres (CRDCs) competition and is intended to supplement the guidance document NIHR CRDC Guidance.
These FAQs will be updated regularly on the NIHR CRDC FAQs page until two weeks before call close, i.e., Wednesday 19 June 2024. Applicants are advised to check the NIHR website frequently for the latest updates.
Eligibility criteria
What is my organisation's average volume of NIHR CRN portfolio adopted, commercially sponsored clinical trials open to recruitment since Q1 2022/23?
Please get in contact with your Local Clinical Research Networks (LCRN) representative. The average volume of NIHR CRN portfolio adopted, commercially sponsored clinical trials open to recruitment since Q1 2022/23 data has been shared with the LCRNs. They will be able to share this data with potential CRDC applicants.
What is the timeframe used to calculate the average volume of NIHR CRN portfolio adopted, commercially sponsored clinical trials at the NHS organisation?
The average volume of NIHR CRN portfolio adopted, commercially sponsored clinical trials is determined by calculating the quarterly average number of trials open to recruitment. This calculation spans from Q1 2022/23 to Q4 2023/24, covering a two-year period. This average is not based on annual data but rather on the combined quarterly figures over the period.
For NHS Organisations that do not meet the eligibility criteria, can they be a spoke as part of a NIHR CRDC application?
NHS Organisations that do not meet the eligibility criteria, but would like to be involved in the NIHR CRDCs, are encouraged to get in touch with NHS Organisation(s) that may be eligible to explore involvement.
Would centres that have a strategy to specialise in Phase I and IIa be eligible to apply?
NHS organisations remain eligible to apply provided they meet the eligibility criteria outlined in the guidance. However, applicants should consider the scope of NIHR Clinical Research Facilities (CRFs) and ensure that their proposed Commercial Research Delivery Centre (CRDC) complements this rather than competes. CRDCs may support both early and late phase trials, contingent upon the centre's demonstrated capabilities and expertise, along with the availability of appropriate facilities.
Can the CRDC focus on a particular disease area or phase of trial?
NIHR CRDCs should not specialise in particular disease areas or trial phases. As per the selection criteria outlined in the guidance, CRDCs will be expected to deliver a range of trials to meet industry needs.
Could spokes from one CRDC site be utilised by another CRDC?
Organisations may be a partner for more than one CRDC. However, given that there will be variations in the CRDCs' governance, strategies and delivery models, it is the lead organisation's responsibility to ensure that the spoke sites are able to comply with the designated CRDC's requirements. Similarly, spoke sites must ensure that they are able to comply with the strategy of the lead organisation and have the capacity and capability to deliver the relevant activities outlined in the applications.
What was the rationale for the minimum average volume of NIHR CRN portfolio adopted, commercially sponsored clinical trials at the NHS organisation being 15 studies?
The eligibility criteria are established to ensure that NHS Organisations tasked with delivering the Commercial Research Delivery Centre (CRDC) possess a robust track record of successfully conducting commercial research, while adhering fully to nationally mandated processes.
Can a consortium of organisations apply if collectively they meet the average number of studies with one of the organisations applying as the lead?
Only one lead NHS organisation can apply as a host organisation for the Commercial Research Delivery Centre (CRDC) and they must meet all the eligibility criteria as laid out in the guidance. The lead organisation must meet the minimum of 15 commercial trials on the CRN/RDN portfolio. Each eligible NHS organisation may submit one application only.
Are there any specific requirements needed for the proposed CRDC Director?
The Director must have suitable experience and expertise in leadership within a commercial research environment. Please refer to the guidance for further details.
Will the current PRC's automatically become CDRC's?
The NIHR CRDC funding call is an open competition, and an independent Funding Committee will make recommendations to the Department of Health and Social Care (DHSC) on the designation and funding of the NIHR CRDCs. All existing PRCs will need to apply as per the process outlined in the guidance.
If a spoke site increases capacity and capability throughout the duration of the award, and then meets the eligibility criteria, would the site be able to get CRDC designation?
Once the CRDCs have been designated, there will not be additional CRDCs during the course of the CRDC's award period, i.e., until 31 March 2032. We will consider other initiatives to support delivery of commercial studies and will communicate these as they arise.
Can a proposed CRDC have a co-hub collaborative model?
Only one lead NHS organisation can apply as a host organisation for the Commercial Research Delivery Centre (CRDC) and they must meet all the eligibility criteria as laid out in the guidance. The lead organisation must meet the minimum of 15 commercial trials on the CRN/RDN portfolio. Each eligible NHS organisation may submit one application only.
Are GP practices eligible to apply as the host organisation?
All NHS Organisations are able to apply, provided the lead organisation meets the eligibility criteria.
For applications that include a Hub and Spoke model, would the average volume of NIHR CRN portfolio adopted, commercially sponsored clinical trials open to recruitment used to assess eligibility include both the Hub and the spoke sites' data?
No, the lead organisation, as a standalone entity, must have at least 25 NIHR CRN portfolios adopted, commercially sponsored clinical trials open to recruitment since Q1 2022/23 will be eligible for hub and spoke funding. CRN portfolio adopted commercial trials of partner(s) or spoke site(s) will not be counted.
If the host NHS organisation does not reach 80% recruitment to time to target (RTT), will they receive a cut to funding?
For infrastructure competitions where applicants can apply for funding up to a fixed amount, such as Commercial Research Delivery Centres (CRDCs), those not meeting 80% performance of their sponsored CRN portfolio studies, may only be allowed to apply for up to 90% of the funding envelope set out in the guidance for that scheme. For example, if the funding envelope for each CRDC was £7m over seven years, they would only be able to apply for up to £6.3m; if the funding envelope was £3.5m per CRDC, only £3.15m could be requested.
If NHS Organisations have an average volume of NIHR CRN portfolio adopted, commercially sponsored clinical trials open to recruitment that falls just below the minimum threshold, will this be rounded up to 15, and the NHS Organisation deemed eligible?
For NHS Organisations with an average volume of NIHR CRN portfolio adopted, commercially sponsored clinical trials open to recruitment that falls just below the minimum threshold (between 14 and 15), this has been rounded up to 15 and the Organisation will be deemed eligible. Please refer to your LCRN to confirm.
Could the lead NHS organisation of the CRDC sub-contract to another site to deliver in the region?
The host NHS Organisation is expected to lead the CRDC and carry out the majority of the programme of work. Applications proposing other delivery models may be submitted and will be reviewed by the independent funding committee on a case-by-case basis.
Could a list of eligible NHS organisations be made available?
The eligibility of individual NHS organisations is confidential and we are unable to share this information. Please contact your LCRN to confirm the eligibility status of your organisation.
Should a study be opened at multiple different sites, do these only count as one study?
Studies are only being counted for the NHS Organisations contracted to deliver the study, and therefore would not be counted across multiple different sites within the same contracted Organisation. All NHS Organisations are eligible to apply, however, only one Organisation can be the lead applicant, and only their performance data will apply.
What are the minimum requirements for the "dedicated space" for the CRDC?
All applicants will be expected to demonstrate that the centre has the appropriate facilities and expertise in place to undertake the delivery of industry sponsored research and commercial collaborative studies across the whole clinical trials pathway. It is expected that the space and facilities for the CRDC is proportionate to the strategies and plans proposed in the application.
PPIE and Research Inclusion
How will PPIE and Research Inclusion work together in the Commercial Research Delivery Centre?
Successful CRDCs are expected to embed PPIE and Research Inclusion in all aspects of their infrastructure delivery. PPIE and Research Inclusion are two separate domains with some overlap. Your PPIE plans should encompass research inclusion to ensure you are reaching out to relevant communities and involving those that the research is most likely to affect. Research Inclusion activity should be distinct from PPIE activities and you should consider aspects such as your workforce and how your centre can align with and contribute to the aims outlined in the NIHR's Research Inclusion Strategy 2022-27.
If our NHS Organisation already has an inclusive PPIE strategy, do we still need to develop one for the CRDC should we be successful?
We expect successful CRDCs to come up with a bespoke PPIE plan in their proposal. While we acknowledge the bespoke CRDC PPIE strategy would be aligned with the one developed and employed by the host NHS organisations, the CRDC PPIE strategy must outline the specific areas that would be delivered as part of the CRDC and its funding.
What are the details needed for the proposed CRDC PPIE lead(s)?
We expect a PPIE lead(s) to be allocated as part of the CRDC application. This role(s) should be committed to enabling the delivery of the PPIEP plans, as part of the proposed strategic objectives for Patient and Public Involvement, Engagement and Participation.
Scope
Are all NIHR CRDCs expected to propose a hub and spoke model?
No, the hub and spoke model is not expected for all proposed NIHR CRDCs, and is dependent on eligibility as per the guidance. NHS organisations eligible to apply for the hub and spoke model funding with 25-70 CRN/RDN portfolio adopted commercial trials are not mandated to apply for a hub and spoke model should they not wish to do so. but should set out the rationale for this in the application. Those eligible to apply with over and over 70 CRN/RDN portfolio adopted commercial trials must set out a hub and spoke model in their application.
Will the CRDC be allowed to run any non-commercial studies?
Our expectation is that each NIHR CRDC will underpin a portfolio of work supported by commercial research funders. They may support studies of agreed publicly important non-commercial research if agreed with NIHR/DHSC.
Are primary care NHS organisations eligible to host a CRDC?
NHS organisations are eligible to apply should they have a minimum of 15 commercial trials on the CRN/RDN portfolio as set out in the guidance.
How will the NIHR promote the CRDCs to industry?
In addition to the support of the NIHR business development team, which promotes NIHR infrastructure and other offers to commercial companies, NIHR and DHSC are also working with ABPI to increase the visibility of the CRDCs. It is expected that the CRDCs and the CRDC Network will develop and coordinate the network's industry engagement strategies to utilise the value of CRDCs to commercial companies.
Is there a formal evaluation of the PRCs available?
A formal evaluation of the PRCs is not available. However, the KPIs for PRCs are reviewed regularly by DHSC. The CRDCs will be reviewed annually by NIHR going forward through a standard annual reporting process.
Is there a plan for a strong geographical spread of CRDCs?
The NIHR CRDCs will be designated and funded according to quality, as per the recommendation of the independent funding committee. However, we anticipate there will be a footprint across the country.
Would centres that have a strategy to specialise in Phase I and IIa be eligible to apply?
NHS organisations remain eligible to apply provided they meet the eligibility criteria outlined in the guidance. However, applicants should consider the scope of NIHR Clinical Research Facilities (CRFs) and ensure that their proposed Commercial Research Delivery Centre (CRDC) complements this rather than competes. CRDCs may support both early and late phase trials, contingent upon the centre's demonstrated capabilities and expertise, along with the availability of appropriate facilities.
How will the CRDCs interface with the recent DHSC vaccine funding programme?
Commercial Research Delivery Centres are required to work collaboratively with all parts of the clinical research infrastructure, including but not limited to wider NIHR research delivery infrastructure such as Clinical Research Facilities and the Research Delivery Network; and other NIHR supported collaborations such as the UK Forums for the Vaccines Innovation Pathway.
Is there a geographic limit on where spokes can be located?
Spoke sites must be located within England.
Can spoke sites leverage commercial income/profit to support the hub-spoke model?
As per the guidance, we expect NIHR CRDCs, including those with a hub and spoke model, to demonstrate how full cost recovery will support continued delivery of the centre and work towards sustained delivery.
What is the expectation in terms of support provided by the Hubs to spoke sites?
The host organisation of a CRDC, or the organisation acting as the Hub, is expected to provide support as detailed in the application. The variation among spoke sites is acknowledged and it is expected that the Hubs will need to assess the support required by the spokes site and plan the CRDC's strategy and resources accordingly.
What is meant by "repeat business" and how will this be measured?
Repeat business in this instance refers to where industry partners return to an NHS organisation to utilise its services again after having previously engaged with it. This is based on the idea of building long-term relationships with industry partners, who choose to continue partnering with organisations due to satisfaction with previous experiences. Repeat business is often considered a key indicator of satisfaction, as well as the effectiveness of an organisation's research delivery including the service, and quality. This will be measured by assessing the continued volume of open commercial clinical trials over a sustained period, showing a commitment to successful delivery of commercial clinical trials.
Can Specialist or disease specific NHS trusts or organisations act as a spoke for a disease agnostic Hub?
Yes, NHS trusts and other organisations that specialise in one disease area may act as a spoke, provided the host organisation meets the eligibility criteria outlined in the guidance and the proposed CRDC will support commercial studies of all disease areas.
Finance
Will funding be provided for capital equipment, refurbishment or repurposing of facilities?
No, CRDC funding cannot be used for equipment over £5,000, repurposing or refurbishment of buildings. The NIHR has an annual Capital Investment Call to which CRDCs can apply. CRDCs may use additional funding or revenues leveraged to further invest in their infrastructure.
Is there an expectation that a certain proportion of funding under the hub and spoke model will be distributed to the spokes?
There is no set limit on the amount of funding that should be retained by the Hub or provided to the spokes. We invite applicants to propose a funding distribution model that aligns with their strategic and operational objectives. This should include a clear demonstration of feasible plans aimed at enhancing the capacity to conduct commercial research in smaller NHS organisations, primary care, community and social care settings, all within the framework of the hub and spoke model.
Can an NHS Organisation apply for hub and spoke funding, but only be successful for core funding?
Funding recommendations will be at the discretion of the independent Funding Committee. All of the selection criteria must be met to be deemed fundable.
Can applicants apply for multiple categories of funding e.g. Core funding and hub and spoke funding?
Applicants can apply for the following combinations of funding and apply up to the maximum indicated below, depending on eligibility:
A: Core funding & hub and spoke funding: £3.5M + £3.5M (£7M)
B: Lower core funding & hub and spoke funding: £1.225M + £3.5M (£4.725M)
C: Core funding only: £3.5M
Further information on funding is outlined fully in the published guidance.
Is the funding for the hub and spoke model fixed, irrespective of the number of spokes?
Applicants may apply for up to £3.5m for the hub and spoke funding. It is expected that the amount of funding applied for is proportionate to the proposed model. The hub and spoke funding is separate to the core funding. Please refer to the guidance for the maximum core funding your organisation may apply for.
Other
Will there be a national standardised approach to the CRDCs' governance?
Applicants will be expected to describe the management and governance arrangements for their proposed NIHR CRDC. This is expected to be in line with existing host infrastructure arrangements. Please refer to the guidance for further details.
Will the webinar slides be shared?
The recording and a copy of the slides has been shared with webinar attendees. However, will be made available upon request by contacting the Infrastructure Team at infrastructure@nihr.ac.uk.
How many CRDCs are expected to be funded?
There is a set funding envelope for the scheme. The number of successful CRDCs will depend on the balance of applications according to the eligibility criteria A-C, the quality of applications and the recommendation of the independent funding committee.
What metrics will be used to measure activities in the CRDC following designation?
The NIHR will work with DHSC and the Advisory Group for the CRDC Network, once convened, to identify the key monitoring metrics relevant to CRDCs based on the aim of the scheme and the guidance provided for this funding competition. These will be aligned with the system metrics published in the Government response to the O'Shaughnessy Review where appropriate. The metrics will be reviewed on an annual basis through the scheme's reporting processes.
Could organisations with current NIHR infrastructure funding use the existing space to deliver the CRDC?
NHS Organisations in receipt of other NIHR Infrastructure funding (e.g. Clinical Research Facilities/ Clinical Trial Units) are eligible to apply. However, the space dedicated to and in receipt of CRF funding should be used to deliver CRF activity. Applicants must ensure that there is sufficient space and resources to ensure the delivery of the proposed CRDC in addition to existing infrastructure.
Can an unsuccessful CRDC be included as a spoke site for a successful CRDCs?
Unsuccessful applicants may participate as a spoke site for a successful Commercial Research Delivery Centres (CRDC). However, the funding allocation for a CRDC would have been finalised during the contracting stage of the process, and there will be no additional budget available to include additional partners.
How will the successful CRDCs form contractual relationships with spokes under the hub and spoke model?
Upon successful NIHR CRDC designation, CRDCs will be asked to provide a list of "Partners" that will be included in the contract. It is then the expectation that partnership agreements will be put in place within the first 6 months of the award. Partnership agreements must be reviewed by NIHR to ensure alignment with the funding contract before execution.
RMS Application Form
How much detail about the spoke sites is needed in the application?
Applicants should set out sufficient information to allow the Independent Funding Committee to assess whether the proposal meets the selection criteria for the scheme.
Review Process
Does each of the selection criterion have a different weighting?
For an application to be considered fundable, it must meet all the outlined selection criteria in the guidance. These criteria carry equal weight.