Research Question

Before developing your protocol in detail, you should have developed a clear and focused research question that broadcasts the overall message of the study. The question will drive the whole research process and inform the type of methodology used. It should include all the key variables of interest such as (as applicable):

  • Intervention/topic area
  • Participants
  • Design
  • Outcome
  • Setting

It is essential that existing sources of evidence, especially systematic reviews are considered. Research which duplicates other work unnecessarily or which is not of sufficient quality to contribute something useful to existing knowledge is in itself unethical.

When designing a research proposal it is important that all the key stakeholders are involved. The Funding Development Team (refer to funding page) will support this function.

If you would like to Trust to Sponsor a proposal you should contact the FDT at the earliest possible point, in particular if you are using the services of the Research Design Service (RDS) and/or a Clinical trials Unit (CTU). All stakeholders should be involved from the beginning of the process to ensure the best quality support.

Write your Protocol

The protocol can take some time to prepare and finalise so should be developed in parallel with developing the costs for your research. You should look to include the following in your protocol:

  • Title
  • Abstract
  • Contact details for:
    • Sponsor
    • Chief Investigator
    • Principal Investigators
  • Background
    • Why are you researching the area?
    • What is the previous evidence or gaps in knowledge?
  • Aims, objectives, purpose
  • Design and methodology
    • Qualitative, quantitative
    • Retrospective, prospective
    • Interventions, surveys, tests, observations
    • Sample size, data analysis (see statistical support below)
    • Selection, withdrawal of subjects
    • Process for informed consent
  • Ethical considerations
  • Financing and Insurance
  • Dissemination and implementation
  • References
  • Appendices (e.g. questionnaire and patient information sheet)

If you are involved in a clinical trial of an investigational medicinal product, you should ensure that your protocol complies with the requirements of Good Clinical Practice, as this is now a legal requirement under Clinical Trials Regulations.