CI Checklist Before Seeking Approval

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
• Trial Registration (before the first participant is recruited and no later than six weeks after)
• 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):
• 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 Summary of Product Characteristics (or equivalent) developed/identified.