Frequently Asked Questions
Background
CLRN Host Organisation CLRN Clinical Director CLRN Board CLRN Executive Group CLRN Core Team CLRN Funding Industry Studies and the CCRN What are the aims of the National Institute for Health Research (NIHR) Comprehensive Clinical Research Network (CCRN)? The NIHR Comprehensive Research Network will provide a world-class infrastructure for clinical trials and other well designed studies in all areas of disease and clinical need within the NHS in England. It will work together with UKCRN’s existing Topic Specific Clinical Research Networks and the Primary Care Research Network to support participation in a high quality national portfolio of clinical trials and other well-designed studies.
The aims of CCRN are:
- To ensure that patients and healthcare professionals from all parts of the country and from all areas of healthcare can take part in and benefit from clinical research
- To improve the quality, speed and coordination of clinical research by removing the barriers to research within the NHS
- To streamline and performance manage NHS support for clinical studies to ensure that the costs of research are met in a timely and efficient manner
- To unify and streamline administrative procedures associated with regulation, governance, reporting and approvals
- To strengthen research collaboration with industry and ensure that the NHS can meet the health research needs of industry
- To further integrate health research and patient care.
What topics are covered by CCRN? CRN will support research in all areas of disease and clinical need. However all studies supported by the Networks must be included in the UKCRN portfolio.
What is the coverage of CCRN? CRN covers the whole of England.
How is CCRN structured? CCRN consists of 25 Comprehensive Local Research Networks (CLRNs) which are the primary vehicle for providing infrastructure to support study involvement. CLRNs will encourage participation in a range of high quality clinical studies in the UKCRN portfolio and provide a coordinated and efficient infrastructure of research personnel, facilities and other support services such as pharmacy, pathology and information systems to support recruitment.
A map of the constituent organisations within each confirmed CLRN is available here.
How were CLRNs identified? The Department of Health asked the UKCRN Coordinating Centre to make recommendations on the structure and coverage of the CLRNs. Ten individuals were identified (one in each SHA area), and seconded to the UKCRN Coordinating Centre to facilitate regional/local input. In developing the CLRN configurations, UKCRN considered the importance of mapping research onto clinical activities of NHS organisations, the R&D activity within each area, any existing clinical and academic collaborations, the potential to identify clinical leadership and the natural health economy across primary, secondary and tertiary care services. Chief Executives of NHS organisations were then given the opportunity to comment on the proposed configurations. The Department of Health had responsibility for final approval of the CLRN configuration.
How do CLRNs operate? Each CLRN is led by a Clinical Director, who will provide leadership for all aspects of the CLRN’s work, developing the CLRN strategy and overseeing its implementation working closely with an Executive Group and a Senior Manager. The Executive Group will include representation from primary, secondary and tertiary care and mental health. Each CLRN also has a Network Board which includes representation from all the NHS organisations and other stakeholders, in the CLRN area. The CLRN host organisation provides the CLRN with the high quality management services it requires, such as human resources, finance, premises and facilities.
What is a CLRN host organisation?
The host organisation is the NHS organisation that holds the contract, on behalf of the CLRN, with the Department of Health. Its role is to provide the high quality management services, such as human resources, finance, premises and facilities to ensure the CLRN functions effectively at operational level. The host organisation is not responsible for the CLRN operational plan – the CLRN operational plan is led by the Clinical Director and Executive Group (see above). The host organisation provides the administrative services to facilitate the CLRN, for example to ensure that appropriate facilities are provided for the core team, and to ensure the efficient delivery of CLRN funding and other resources to all CLRN members.
Who are the CLRN host organisations? A list of the CLRN host organisations is
available on the UKCRN website How were CLRN host organisations selected? NHS organisations were invited to submit applications to become a host organisation earlier this year. Applications were reviewed by a panel led by Department of Health with input from the Topic Specific and Primary Care Research Networks. Selection was based on the organisations’ relevant experience, expertise and suitability in accordance with the published criteria set out in the
call for applications.
As the contract holder, is the host organisation responsible for the strategic development, direction and leadership of the CLRNs activities? No, the strategic development, direction and leadership of the CLRN is the responsibility of the Clinical Director, working closely with the Senior Manager and Executive Group (see above).
Will the CLRN host organisation employ all CLRN-funded staff? It is not expected that the host organisation will employ all CLRN-funded staff. As with the other Research Networks that form UKCRN, it is anticipated that the host organisation will employ and accommodate a core team that will provide overall administration and support day to day management of the CLRN. Other CLRN-funded staff will be deployed throughout the Network, with effective and suitable employment and accommodation arrangements being agreed between the Network and the relevant constituent NHS organisations.
Who are the CLRN Clinical Directors? A list of the CLRN Clinical Directors is
available on the UKCRN website.
What is the role of the Clinical Director?
The Clinical Director provides leadership for all aspects of the CLRNs work, developing a CLRN operational plan and overseeing its implementation. A key part of that will be to encourage local activity, working with local clinicians to increase their participation in studies contained in the UKCRN national portfolio, building upon local clinical strengths and research interests and priorities. The Clinical Director also Chairs the CLRN Executive Group and sits on the Network Board.
Who are the CLRN Clinical Directors? A list of the CLRN Clinical Directors is
available on the UKCRN website How were Clinical Directors appointed? The UKCRN Coordinating Centre released a series of national calls for applications earlier this year and interviews took place during spring/summer. The national interview panel consisted of representatives from the Department of Health, UKCRN Coordinating Centre and the Topic Specific and Primary Care Research Networks. The panel assessed the candidates according to the required skills/experience outlined in the
Clinical Director job description. The panel then made recommendations to the CLRN Board who were asked to ratify the recommendation. This was essential to ensure local ownership of this important role.
Who can apply to become a CLRN Clinical Director? The Clinical Director can be a clinician of any profession from any CLRN member organisation. Clinicians must either have a full contract with an NHS organisation, within the CLRN for this they wish to be Clinical Director, or hold an honorary contract.
What skills does a Clinical Director need?
The Clinical Director is expected to have substantial knowledge of the local health research economy, meaning knowledge and/or involvement with the researchers, research activities, structures and strategies of local NHS organisations, academic units, and a demonstrable understanding of the different issues that affect different NHS sectors and constituencies. The Clinical Director will also need substantial experience of conducting later phase clinical trials and other well designed studies, knowledge of the governance and legislative framework for conducting clinical research studies and experience of successful coordination of clinical studies at a national level, either individually or in collaboration.
Is the Clinical Director role full time? The Clinical Director post is part time (approximately 0.5 wte/5 programmed activities per week) for a fixed term of 5 years in the first instance.
How will Clinical Directors be appointed in future? CLRN Clinical Directors will be appointed by a national panel, which will include the Chair of the relevant CLRN Board who will provide local input.
What is the role of the Network Board? The CLRN Board includes representation from all the NHS organisations, and other stakeholders such as existing Topic Specific Clinical Research Networks, in the CLRN area. The Board takes broad oversight of the activities of the CLRN and ensures that the interests and priorities of the constituent organisations are carefully considered and inform the activities of the CLRN. The Board also has a role to ratify the appointment of the first Clinical Director.
What is the membership of the Network Board? Each Network Board has representatives from all of the CLRN’s constituent NHS Trusts. Other stakeholders, such as representatives from higher education institutions and UKCRN Networks may also be members of CLRN Boards. The CLRN Clinical Director will have full membership of the Network Board, with the Senior Manager in attendance. Each CLRN Board will include a senior representative from the UKCRN Coordinating Centre. Board membership will be reviewed at the end of year one.
How were CLRN Board members selected? Chief Executives of NHS organisations were invited to nominate representatives from their organisations to sit on the CLRN Board in their area for the first year. At the first meeting of the Board, representation from other stakeholders in the CLRN area such as higher education institutions and topic Local Research Networks was discussed and invitations extended to additional representatives.
Who Chairs the Network Board? The Chair of the Network Board is employed by a constituent Trust or other relevant local stakeholder and is elected by the members of the Board. The Chair will not be the Clinical Director of the CLRN and must be independent from the CLRN host organisation.
How often does the Network Board meet? The CLRN Board will meet three times per year for at least the first year.
What will be the role of the Executive Group? The Executive Group will work with the Clinical Director and Senior Manager to develop and implement the CLRN operational plan. The Group will be responsible for the strategic and operational delivery of the Network.
Who will be members of the Executive Group? The CLRN Executive Group will be drawn from across the CLRN and will include at least one representative from primary, secondary and tertiary care and mental health. The shape, membership and organisation of each Executive Group may vary in different CLRNs.
Who will Chair the Executive Group? The Clinical Director will Chair the Executive Group.
How often will the Executive Group meet? The Executive Group will meet on a regular basis, to be agreed by the Clinical Director, to support the operational management of the Network.
How many staff will be employed within the CLRNs? Each CLRN will have a core team of staff, led by the Senior Manager who reports to the Clinical Director. In addition, the core team will include a Lead Research Management and Governance (RM&G) Manager, an Information Officer and an Administrator. The wider staffing profile across each of the CLRNs will vary dependent on local needs but will include Research Nurses/Officers and Research Management staff.
What is the role of the Senior Manager?
The Senior Manager will work closely with the Clinical Director to implement the CLRN operational plan and will play an important role in the day to day running of the CLRN, including the management of resources to support high quality research studies being undertaken within the Network. The Senior Manager is likely to be an individual with considerable experience in managing research that will be able to take responsibility for the day to day running of the CLRN.
What is the role of the Lead RM&G Manager?
The Lead RM&G Manager will lead on research management and governance and help to establish the CLRN Research Management and Governance team. They will manage the local implementation and delivery of national research management systems ensuring that the CLRN fulfils its role in the national processes managed by the UKCRN Coordinating Centre.
When are members of the core team being appointed?
A call for expressions of interest for the roles of CLRN Senior Manager and CLRN Lead RM&G Manager was released in early June with a deadline of end of June. Expressions of interest received are being discussed with the relevant Clinical Director and host organisation HR department. Each interview panel will be chaired by the relevant Clinical Director and will involve a UKCRN Coordinating Centre representative. Core team posts will be appointed in line with local HR policies. The remaining core team posts will be advertised in late summer/early autumn.
Will all members of the core team be employed by the CLRN host organisation?
Yes. The core team (with the exception of the Clinical Director) will be employed by the host organisation.
Where will the core team be based?
A CLRN office will be established in the host organisation where the core team will be based.
When will other CLRN staff be appointed? The CLRN Senior Manager and CLRN Lead RM&G Manager will oversee the process of appointing other CLRN staff once they are in post (likely to be early autumn 2007).
How can I stay informed about job opportunities within the CLRNs? All CLRN job opportunities will be posted on the
UKCRN website. You can also register your interest in receiving information about CRN job opportunities by contacting Rona Cubitt on
r.cubitt@ukcrn.org.uk How will funding flow through the CLRNs? DH will allocate funding to CLRNs in a phased way during the transition period. The first phase of funding (2007/8 financial year) will provide a fixed allocation to each CLRN to establish the CLRN core team and a per capita allocation to CLRNs to contribute towards the costs of recruiting patients into trials and other well designed clinical studies within the UKCRN national research portfolio, their research management and governance. The per capita funding stream will be used in conjunction with the constituent Trusts’ transition funding to support clinical research during the CLRN implementation phase. As CRN is developed, the relevant DH funding will be released from the transitional funding stream and distributed to CLRNs. Stage 2 funding will be available from 2008/09 and will be activity based. Future activity based funding is in addition to CLRN per capita allocations.
Does the CLRN host organisation receive funding to act as host? All CLRN member organisations that employ or host CLRN staff will receive funding for any additional costs of hosting services, such as human resources, finance, premises and facilities.
Will Industry sponsored studies be adopted into the CCRN? Studies sponsored by Industry are eligible to be included in the UKCRN Portfolio provided that feasibility is fully assessed and they meet specific adoption criteria. Industry studies will be reviewed by a CCRN Industry Adoption Panel and if accepted onto the CCRN Portfolio, will be classed as high priority according to NIHR eligibility criteria. Further information is available
here.
Studies which fall within the Topic Specific Networks should be discussed with the Industry Manager within the appropriate Topic Coordinating Centre.
What will happen with non Industry sponsored, Industry funded studies? Investigator Initiated Trials (IITs) which are majority funded, but not sponsored by Industry may be eligible for inclusion onto the UKCRN Portfolio and are classed as medium priority in the NIHR eligibility criteria. They will however be required to go through a non-commercial adoption process to ensure high quality peer review and to ascertain levels of funding and CLRN support. Non-adopted IITs will continue to be supported by R&D Transitional Funding in the interim but will need to be adopted onto the Portfolio by April 09 to ensure access to service support and infrastructure funding. The adoption process for non-commercial studies is currently being developed and more information about this will be available shortly.
Who will be the first point of contact to discuss adoption of industry Studies into the CCRN? A dedicated CCRN Industry team within the UKCRN Coordinating Centre, led by the CCRN Industry Lead, will act as point of contact for enquiries about conducting Industry sponsored trials in the CCRN. Submission for adoption of Industry sponsored trials will be led by the company. CLRNs are asked to contact the CCRN Industry Lead if they become aware of any new studies which may be potentially eligible and benefit from adoption. Consultation with the CCRN Industry team in the UKCRN Coordinating Centre is encouraged at the earliest stage to determine whether the proposal is feasible. The CCRN Industry lead is Jenny Gray (
j.gray@ukcrn.org.uk).
How will the adoption process work? The adoption process will be managed by the CCRN Industry team and will provide either, or both, a Level 1 (top line) feasibility assessment on the suitability of UK study conduct within 2 weeks and Level 2 (detailed) feasibility assessment and adoption onto the Portfolio in a further 4 weeks. The CLRN Industry Managers will be contacted as part of the Level 2 feasibility assessment to obtain Expressions of Interest and potential patient numbers from appropriate network clinicians. This information will be provided to the Adoption Panels for consideration and on adoption the CCRN Industry team will work with the company to support site selection activities. The feasibility and adoption process for the CCRN will broadly reflect that currently used for the Topic Specific Networks, with expert advice being drawn from the Specialty Groups.
What are the Specialty Groups? The Specialty Groups will provide the NIHR CCRN with access to a national network of topic based expertise which can contribute to a wide range of CCRN and UKCRN activities. They will provide topic based expertise and advice in twenty six, specific clinical topics not covered by the Topic Specific Clinical Research Networks (TCRNs). Specialty Group membership will be drawn from the Clinical Leads who have been nominated by each CLRN to provide local focus for identified research priorities. Amongst other activities, the Specialty Groups will provide members and input into adoption panels for both industry sponsored and non industry sponsored studies which are not automatically eligible for the NIHR Portfolio. The groups will not have a remit to drive the portfolio of research in a specific topic area.
How will Industry studies be supported within the CCRN? Each CLRN will have a dedicated Industry Manager who will have specific responsibility for feasibility, timely site set up and ongoing performance management of studies to target. They will be supported by a dedicated CCRN Industry team within the UKCRN Coordinating Centre who will be responsible for initial company contact, managing the study set up process with the participating CLRNs, entering patient accrual onto the Portfolio database, overall study performance management and ongoing communication with the company and networks. The company, CLRNs and CCRN Industry team will work in partnership to set appropriate patient and study targets and will actively performance manage the study at site level and study level to ensure these are achieved.
What are the timelines for the adoption of Industry studies? The CCRN Industry team will start to consider the adoption of Industry studies from end of April 2008. Until the full implementation of the CLRNs and Specialty Groups is complete, studies will be considered on a case by case basis to ensure there is adequate interest and CLRN infrastructure in place to support study set up and delivery. Consideration of all CCRN Industry studies for adoption will be possible from April 2009.
What needs to be in place at the CLRN to enable Industry studies to be adopted? The UKCRN has appointed the CCRN Industry Lead and will build a CCRN Industry team within the UKCRN Coordinating Centre to support Industry sponsored trials. Industry Managers will be appointed in each CLRN as quickly as possible over the coming months. In the interim the CCRN Industry team will liaise in the first instance with the CLRN Senior Managers and Lead RM&G Managers to assess feasibility and to facilitate site set up. Specialty Groups will provide the expertise necessary for Level 1 feasibility and input to Industry Adoption Panels. Whilst the Specialty Groups are being established and Chairs appointed, the Industry team will call upon the expertise of appropriate nominated Specialty Group clinical leads to provide feasibility and input into Adoption Panels. The CCRN Industry team are mapping which CLRNs are ‘ready’ and have the necessary research infrastructure in place to actively support and performance manage Industry studies.
Why is it so important for the CLRN to be ready? Industry is expecting that the CCRN will ensure their adopted studies are set up and recruitment managed and delivered to defined timelines and targets. Without the necessary research nurses and research infrastructure in place the CLRN cannot make commitments to delivery of studies and targets. Industry’s expectations are high and the CLRN must ensure it can add value to adopted studies at local sites.
What about ongoing Industry sponsored trials where sites have already been set up within the network? Ongoing studies will not be adopted onto the Portfolio. Industry sponsored trials require a full adoption process to assess feasibility, eligibility and resource implications and to ensure the networks can add value to the study. The CLRN must be able to provide the necessary resource and actively performance manage studies before Industry sponsored studies can be adopted onto the Portfolio. Existing and new studies will continue to be able to run outside the network infrastructure until the CLRN is in a position to support adopted studies.
Will Industry studies have access to NIHR CSP (Central System for gaining NHS Permission)
? All Industry studies adopted onto the NIHR CCRN Portfolio can gain NHS approval via NIHR CSP. At a later stage CSP is expected to be available for non adopted Industry studies as a costed service.
Will Industry adopted trials be required to use the model Clinical Trial Agreement (mCTA) and new UKCRN costing template? All Industry trials adopted into the CCRN should be costed using the standard costing template and be set up under the mCTA. The UKCRN costing template has been designed to provide a standard tool to calculate the prices associated with individual Industry sponsored trials. The CLRN Industry Managers will be responsible for agreeing the costing and contracts with each participating Trust and where issues arise, the CCRN CC Industry team can provide further support with negotiations with the company.
Where can I find out more about Industry adopted studies and the CCRN? 
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