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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.