Essential documents checklist: Title Of Document Purpose Investigator TMF Sponsor File Comment File Where applicable, any To clarify trial documents have X X (if related to been translated, and to translations and back translations documents kept in Sponsor File) provide evidence that the of essential documents translation was appropriate. Risk assessment documentation To document the process and X outcome of risk assessment, and how this informed the set up and management. Any and guidelines, e.g. To document the systems put X in place to address trial risks Monitor Plan, Communication and to ensure quality data is Plan, Statistical Analysis Plan generated and the subjects’ safety and wellbeing is safeguarded. Investigator’s Brochure X X or To document that relevant and current scientific Summary of Products information about the Characteristics and updates investigational product has been provided to the investigator Signed Protocol and To document investigator and X X X sponsor agreement to the amendments, if any, and sample (PI signed) (PI and CI (unsigned) protocol/amendment(s) and Case Report Form (CRF) and any signed) CRF revisions Information given to trial subject and any revisions thereof: - Master Informed Consent Form To document the informed X X X consent - Any other written information To document that subjects will X X X be given appropriate written
Essential documents checklist: Title Of Document Purpose Investigator File TMF Sponsor File Comment Where applicable, any translations and back translations of essential documents To clarify documents have been translated, and to provide evidence that the translation was appropriate. X X (if related to documents kept in Sponsor File) Risk assessment documentation To document the process and outcome of risk assessment, and how this informed the trial set up and management. X Any and guidelines, e.g. Monitor Plan, Communication Plan, Statistical Analysis Plan To document the systems put in place to address trial risks and to ensure quality data is generated and the subjects’ safety and wellbeing is safeguarded. X Investigator’s Brochure or Summary of Products Characteristics and updates To document that relevant and current scientific information about the investigational product has been provided to the investigator X X Signed Protocol and amendments, if any, and sample Case Report Form (CRF) and any revisions To document investigator and sponsor agreement to the protocol/amendment(s) and CRF X (PI signed) X (PI and CI signed) X (unsigned) Information given to trial subject and any revisions thereof: - Master Informed Consent Form To document the informed consent X X X - Any other written information To document that subjects will be given appropriate written X X X
UoB-CLN-ESD-QCD-001%20Essential%20Document%20Checklist%20CTIMPs%20v.%201.0%20(EAv1.0).docx