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Support available

Support can be accessed during protocol development and during the trial itself. Support accessed during protocol development is not charged for and must be negotiated depending on PCTU capacity. This support is important in relation both to successful funding and successful projects and we encourage all researchers to take full advantage of the support offered this stage. 
We often encourage researchers to also link with the London Research Design Service for further support in developing their application.

Services accessed after trial funding is secured must all be adequately costed and agreed beforehand. We will expect to recover the true costs of our engagement in a study in terms of staff costs and consumables.  

Such funding supports staff employed by the unit to work across a range of trials, such as data managers, statisticians, health economists, quality assurance officers, administrators and the unit manager.

Areas in which the unit supports trial are:      

    • In protocol development

  1. Statistical advice prior to submission
    1. Advice about sample size calculation
    2. Advice about statistical analysis plan in protocol development
    3. Advice about trial design
  2. Other field specific advice about:
    1. health economics analysis
    2. data management
    3. quality assurance
    4. trial co-ordination
    5. Review and contribution to study specific SOPs
    6. Agree level of PCTU support/costings


    • At Set up and during trial

  3. Randomisation service
  4. Statistical Services
    1. Statistical analysis planning
    2. Statistical advice and analysis
    3. Contribution to report writing
  5. Data Management
    1. Data management advice
    2. Database advice and set-up
  6. Quality Assurance
    1. Study Risk Assessment
    2. Study quality assurance/quality control planning
    3. Advice on clinical trial regulatory requirements and research governance
    4. Access to and advice about CTU endorsed SOPs
    5. Review and contribution to study specific SOPs
    6. Agree level of PCTU support/costings
  7. Health Economic Services
    1. Economic evaluation
    2. Contribution to report writing
  8. Administrative support
  9. Senior Statistician advice and presence on steering committees
  10. Senior Health Economist advice and presence on steering committees
  11. Senior trial management advice
  12. Trial coordinator support
  13. Trial monitoring

The unit does not provide advice that can be accessed elsewhere. For trials led from Barts and The London School of Medicine and Dentistry, detailed advice about research governance, ethical approval and MHRA procedures please see Barts and The London joint research office.