A well-formulated protocol, even in outline form, will help other stakeholders in the clinical trial to make an accurate and informed judgment of the study’s feasibility. The Joint Research Compliance Office can offer assistance with developing the protocol (contact details below).

The following elements will need to be addressed:

  • Title
  • Abstract
  • Contact details for: sponsor; chief investigator; principal investigators
  • Background: Why are you researching the area? What is the previous evidence/gaps in knowledge?
  • Aims/objectives/purpose
  • Design/methodology: qualitative/quantitative; retrospective/prospective; interventions, surveys, tests, observations; sample size/data analysis; selection/withdrawal of subjects; process for informed consent
  • Ethical considerations
  • Financing and insurance
  • Dissemination and implementation
  • References
  • Appendices (eg questionnaire, patient information sheet)

Please note that with clinical trials of investigational medicinal products, the protocol must comply with the requirements of Good Clinical Practice, as a legal requirement under Clinical Trials Regulations.

Resources

TypeWhere to find
Key contacts JRCO
Useful links JRCO - develop proposal
CT Toolkit - protocol development
CT Toolkit - final protocol
NIHR benchmark Prior to NIHR 70-day benchmark
Process map links This activity occurs in the feasibility stage:
Imperial College London as sponsor
Imperial College Hospital NHS Trust as sponsor