Clinical research process

This page is a guide to what you need to consider when preparing for your research.

Depending on the nature of the research, not all will be required, and there may be other additional considerations not listed here.

 

Clinical research process chartFunding and contractsStudy preparationSponsorship and approvalsTrainingResourcesClinical research conduct

Prepare project proposal, and then:

 

  • Prepare project budget – review sponsor role and include monitoring in budget if required
  • Apply for and secure funding
  • Initiate contract discussions (if applicable)
  • Obtain internal/departmental approval
  • Study classification (CTIMP, device trial or clinical research study)
  • Write protocol (if research is CTIMP, submit to the Research Governance, Ethics & Assurance (RGEA) Team with risk assessment for early review)
  • Ethics application procedure selection (NHS REC or CUREC)
  • Obtain peer review (may be part of funding process)
  • Generate other documents required for ethics applications
  • Submit documents to RGEA team for sponsorship review
  • RGEA team approval of sponsorship and insurance cover
  • Submit application to HRA if required, for NHS REC review and HRA approval
  • Submit to relevant regulatory bodies, such as MHRA, if required, for regulatory approval
  • Communicate with sites
  • Register on public database (if required)
  • Intervention and/or laboratory organisation, supply and logistics
  • Data management systems, SOPs, training, procedures and interventions in place
  • Initiate research

See also