QUESTIONS FOR RESEARCHERS

• What does a CTU do?
• What if my closest UKCRC Registered CTU is not involved in the area of research I'm interested in?
• I have a new clinical research proposal and would like to develop this with a UKCRC Registered CTU. When is the best time to make contact?
• What is the difference between Full and Provisionally Registered Units?
• Should I work with a Provisionally Registered Unit?
• How do I find out which CTU is working in my disease area?
• How do I find out which CTU specialises in my methodological area?
• How do I find out which CTU specialises in my specific type of research study?
• How do I find out which CTU has experience of working with a particular funding body?
• Do I have to work with the CTU that is closest to me?
• How do I choose which CTU to work with?
• Will CTUs require funding to work with me?
• How do I contact a CTU?
• Are the registered CTUs linked to the Clinical Research Networks?
• Do I have to work with a Registered CTU?
• Should I work with a CTU or NIHR Research Design Service (RDS)?

QUESTIONS FOR CTUs

• Can any CTU apply for UKCRC Registration?
• What do CTUs need to do to become UKCRC Registered?
• Who decides whether a CTU should be UKCRC Registered?
• Will there be further calls for CTU Registration?
• How can I make sure that I receive updates about UKCRC Registered CTUs and news of further Registration calls?
• What funding is available for UKCRC Registered CTUs?
• What is the difference between Full and Provisionally Registered Units?
• Are the registered CTUs linked to the Clinical Research Networks?
• My CTU is a Provisional CTU; when will we be able to apply to become a Fully Registered CTU?
• Will Registered CTUs be reviewed after the initial registration and if so, when will this happen?

ANSWERS FOR RESEARCHERS

What does a CTU do?
CTUs design, centrally coordinate and analyse clinical trials and other well-designed studies. For more detailed information, see the section on Function and Services of Registered CTUs.

Some CTUs specialise in different methodologies (for example RCTs, cluster randomised trials, surgical trials, health services research) and some specialise in one disease type, whereas others are generic units.

Some CTUs have expertise in specific phases and types of clinical trials, others have expertise in all phases and types of trial.

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• What if my closest UKCRC Registered CTU is not involved in the area of research I'm interested in?
  
  Clinicians/researchers do not need to work with the CTU that is located closest to them. Clinicians/researchers are advised to work with a CTU that has the relevant expertise in the first instance.

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• I have a new clinical research proposal and would like to develop this with a UKCRC Registered CTU. When is the best time to make contact?
  
  Clinicians/researchers are advised to contact a Registered CTU as early in the process as possible. Ideally, this should be at least three months before a research grant deadline, so that the CTU can offer its experience and knowledge from the initial stages of study development, and to provide the CTU with adequate time to schedule the work required. The CTU will be able to provide advice on the right questions and appropriate design, options for funding etc and will be able to support the Chief Investigator in the preparation of the grant application.

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• What is the difference between Full and Provisionally Registered Units?
  
  All Registered CTUs have provided evidence that their work is of high quality. In order to obtain Full Registration status, CTUs were required to demonstrate:

• a track record and experience of coordinating multi-centre randomised controlled trials or other well-designed studies
• presence of a core team of expert staff to develop studies
• presence of robust quality assurance systems and processes to meet appropriate regulations and legislation
• evidence of longer-term viability of capacity for trials coordination and the development/maintenance of a trials portfolio.

Provisional CTUs tend to be newer and evolving CTUs and have not yet built a track record but have relevant expertise and experience that is worth building on. Evaluation criteria for Provisional Registration were developed for CTUs that did not meet the criteria for Full Registration status, but that are working towards possessing sufficient expertise to enable Full Registration in the future.

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• Should I work with a Provisionally Registered Unit?
  
  Yes. All Registered CTUs have provided evidence that their work is of high quality. Provisional CTUs tend to be newer and evolving CTUs that are developing relevant expertise and experience that is worth building on.

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• How do I find out which CTU is working in my disease area?
  
  The Resource Finder page of this website provides information about the disease areas that each Registered CTU has experience of. Click here to search the database.

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• How do I find out which CTU specialises in my methodological area?
  
  The Resource Finder page of this website provides information about the methodological areas that each Registered CTU has experience of. Click here to search the database.

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• How do I find out which CTU specialises in my specific type of research study?
  
  The Resource Finder page of this website provides information about the specific type of research study that each Registered CTU has experience of. Click here to search the database.

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• How do I find out which CTU has experience of working with a particular funding body?
  
  The Resource Finder page of this website provides information about which Registered CTUs have experience of working with different funding bodies. Click here to search the database.

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• Do I have to work with the CTU that is closest to me?
  
  Clinicians/researchers do not need to work with the CTU that is located closest to them. Clinicians/researchers are advised to work with a CTU that has the relevant expertise in the first instance.

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• How do I choose which CTU to work with?
  
  Clinicians/researchers are advised to work with a CTU that has the relevant expertise, either in terms of the disease, methodological area or type of study being researched in the clinical trial. Clinicians/researchers may also wish to work with a CTU that is located close to them. Note that your chosen CTU may not always have the capacity to collaborate for a number of reasons such as resource constraints. In such an eventuality, you may need to discuss your proposal with an alternative CTU.
  
  The Resource Finder page of this website provides information about the types of study that each Registered CTU has experience of. Click here to search the database.

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• Will CTUs require funding to work with me?
  
  CTUs usually require project grant funding to support the development, management and coordination of the trial. Funding is not usually required to develop the grant application. Funding for the research costs required by the CTU to support the study should form part of the grant application.

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• How do I contact a CTU?
  
  The Resource Finder page of this website provides contact details for each of the Registered CTUs. Click here to search the database.

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• Are the registered CTUs linked to the Clinical Research Networks?
  
  Some Registered CTUs are linked to Research Network Coordinating Centres. However, all Registered CTUs will work closely with the Research Networks to deliver their clinical trials research.

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• Do I have to work with a Registered CTU?
  
  It is not mandatory to work with a Registered CTU, but these units have been assessed by an international panel of trial experts and have demonstrated that they possess the expertise to design, coordinate and analyse clinical trials. Clinicians/researchers are advised to work with a Registered CTU. Increasingly, project grant funders are looking for evidence that applicants have involved a registered CTU.

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• Will there be further calls for CTU Registration?
  
  NIHR CRN CC will advertise calls for UKCRC CTU Registration.  Full information on how to make an application will be available on this website.To register your interest in applying for CTU Registration and to be added to the mailing list, send your name and contact details to the NIHR CRN CC Clinical Trials team on crncc.ctus@nihr.ac.uk.

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• How can I make sure that I receive updates about UKCRC Registered CTUs and news of further Registration calls?
  
  To receive updates about UKCRC Registered CTUs, send your name and contact details to the NIHR CRN CC Clinical Trials team on crncc.ctus@nihr.ac.uk.
  
  To register your interest in applying for CTU Registration and to be added to the mailing list, send your name and contact details to the NIHR CRN CC Clinical Trials team on crncc.ctus@nihr.ac.uk.

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• What funding is available for UKCRC Registered CTUs?
  
  UKCRC Registration itself does not provide funding for CTUs. CTUs may obtain funding for specific projects through the various sources of funding offered by government funding bodies, charities, industry etc. CTUs may also obtain funding for their unit's core infrastructure from some funding bodies. For example, Cancer Research UK provides core funding for a number of CTUs that coordinate and manage cancer trials.

The National Institute for Health Research (NIHR) established a new system in 2008 to provide priming funds to units that intended to conduct NIHR trials. The funding opportunity aimed to offer some stability to Registered CTUs and help address the need for ensuring sufficient research capacity to support expansion in clinical trials as identified in both the national R&D strategy, Best Research for Best Health, and the Cooksey review of UK health research funding. The first round of funding applications has now closed. Further funding opportunities may arise and eligible CTUs will be contacted individually when new opportunities are announced.

NIHR CRN CC undertook a modeling exercise to review the CTU capacity requirements in the UK and to work with UKCRC partners to ensure that there is sufficient support to help address the need for ensuring sufficient research capacity to support expansion in clinical trials. This may result in additional sources of funding being made available for Registered CTUs.  The CTU Capacity Report is available here.

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• What is the difference between Full and Provisionally Registered Units?
  
  All Registered CTUs have provided evidence that their work is of high quality. In order to obtain Full Registration status, CTUs were required to demonstrate:
  
• a track record and experience of coordinating multi-centre randomised controlled trials or other well-designed studies.
• presence of a core team of expert staff to develop studies.
• presence of robust quality assurance systems and processes to meet appropriate regulations and legislation.
• evidence of longer-term viability of capacity for trials coordination and the development/maintenance of a trials portfolio.

Provisional CTUs tend to be newer and evolving CTUs and have not yet built a track record but have relevant expertise and experience that is worth building on. Evaluation criteria for Provisional Registration were developed for CTUs that did not meet the criteria for Full Registration status, but that are working towards possessing sufficient expertise to enable Full Registration in the future.

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• Are the registered CTUs linked to the Clinical Research Networks?
  
  Some Registered CTUs are linked to Clinical Research Network Coordinating Centres. However, all Registered CTUs will work closely with the Research Networks to deliver their clinical trials research.

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• My CTU is a Provisional CTU; when will we be able to apply to become a Fully Registered CTU?
  
  A full review of all UKCRC Registered CTUs will be carried out every 3 years. CTUs with Provisional Registration status will be able to apply for Full Registration status at this 3 year review or alternatively at the point of any future calls for CTU Registration.

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• Will Registered CTUs be reviewed after the initial registration and if so, when will this happen?
  
  UKCRC CTU Registration status will apply for 3 years (Full and Provisional). A review of all UKCRC Registered CTUs will be carried out every 3 years, to ensure that CTUs can still demonstrate the required competencies for Registration status. CTUs with Provisional Registration status will be able to apply for Full Registration status at the review.

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