CI Checklist Before Seeking Approval

CI checklist

The following checklist for Chief Investigators has been designed as a means of checking that the necessary documentation required for the permissions and approvals process are in place.

Chief Investigator Checklist (before seeking approvals) 

  • Sponsor(s) identified and agreements for allocation / delegation of responsibilities (if necessary) are in place
  • Arrangements for appropriate Patient and Public Involvement
  • Input from a statistician secured
  • Peer review complete
  • Arrangements for a data monitoring committee, steering group and/or management group in place (with consent from members)
  • Trial risk assessment carried out, trial management systems and monitoring plan/arrangements in place
  • Funding secured
  • Unique trial number and EudraCT number obtained
  • R&D and local NHS support departments (e.g. pharmacy, labs, radiology etc) consulted and capacity available
  • Contracts and agreements in place including third party agreements where outsourcing of any trial specific test/services is required
  • Insurance and indemnity arrangements in place (non NHS)
  • CVs of investigators (signed and dated)
  • Arrangements for trial supplies in place
  • Arrangements for pharmacovigilance considered
  • Systems in place to ensure trial will be conducted to the principles of GCP and Clinical Trials Regulations
  • Trial Master File established
  • Protocol and associated documents (see relevant stations):
    • EudraCT number on all documentation
    • End of trial defined
    • Safety reporting section of the protocol outlining definitions and reporting requirements
    • All written information provided to/viewed by subjects (e.g. Participant information sheets, consent forms, patient diaries, recruitment advertisements) finalised and version controlled
    • All other relevant trial documentation finalised and version controlled e.g. questionnaires, case report forms, trial specific SOPs
    • Investigator’s brochure or SmPC developed/identified.

Download a PDF copy of the checklist (pdf, 28.12 KB)