If you need advice on how to develop your protocol you can approach the RGI team member, who are able to provide individual support. Instructions and templates for protocol development can also be found in the SOP section of this website.  Alternatively, the R&D Office at the relevant associated NHS Trust may also be able to provide useful advice.

Identifying a 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.

Writing your Protocol

The protocol (RGIT_TEMP_026_Template Protocol for CTIMPs_v5.docx ; RGIT_TEMP_027_Template-Protocol-for-non-CTIMPs_V7.docx)  can take some time to prepare and finalise so it 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
    • Funder
    • 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
  • SAE/SUSAR reporting
  • Monitoring and Auditing
  • Information of IMP if it is CTIMP trial
  • Financing and Insurance
  • Dissemination and implementation
  • References
  • Appendices (e.g. questionnaire and patient information sheet, RGIT_TEMP_031_Guide to Writing a Participant Information Sheet.docx)

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.

Getting statistical support

The RGI recommend that you involve a statistician in the design of your protocol /proposal (if appropriate) to ensure that sample size calculations, randomisation and the proposed analytical approach for results are suitable. The Statistical Advisory Service is set up to help all staff and postgraduate students at the College with advice and support on statistics on a fee-paying basis.

You can find more information about the service on the Statistical Advisory Service (SAS) website.

Development of Case Report Form (CRF)

It is now a requirement for all CTIMP studies to use the Openclinica system as an eCRF for Imperial sponsored studies. For more details please contact the Clinical Data Systems Team