Information provided to subject - advertisement for Subject recruitment(if used) - any other documents given approval / favourable opinion - continuing review of trial (where required) Regulatory authority(ies) To document compliance with · · · · 23 authorisations / applicable regulatory approvals / notifications requirements where required for: - protocol amendment(s) and other documents Curriculum vitae for new To document qualifications and 24 investigator(s) and / or eligibility to conduct trial and/or · · · · sub- investigator(s) provide medical supervision of subjects Updates to normal To document normal values and N/A 25 value(s) / range(s) for ranges that are revised during the · · · medical / laboratory / trial technical procedure(s) / test(s) included in the protocol Medical / laboratory / To document that tests remain N/A 26 technical procedures / adequate throughout the trial · · · tests period - certification or - accreditation or - established quality control and / or external quality assessment or - other validation (where required) Documentation of To document shipment dates, N/A 27 investigational product(s) batch numbers and method of · · · and trial-related material shipment of investigational shipment product(s) and trial-related materials. Allows tracking of product batch, review of shipping conditions, and accountability Certificate(s) of analysis To document identity, purity, and N/A N/A
Information provided to subject - advertisement for Subject recruitment(if used) - any other documents given approval / favourable opinion - continuing review of trial (where required) 23 Regulatory authority(ies) authorisations / approvals / notifications where required for: - protocol amendment(s) and other documents To document compliance with applicable regulatory requirements · · · · 24 Curriculum vitae for new investigator(s) and / or sub- investigator(s) To document qualifications and eligibility to conduct trial and/or provide medical supervision of subjects · · · · 25 Updates to normal value(s) / range(s) for medical / laboratory / technical procedure(s) / test(s) included in the protocol To document normal values and ranges that are revised during the trial · · · N/A 26 Medical / laboratory / technical procedures / tests - certification or - accreditation or - established quality control and / or external quality assessment or - other validation (where required) To document that tests remain adequate throughout the trial period · · · N/A 27 Documentation of investigational product(s) and trial-related material shipment To document shipment dates, batch numbers and method of shipment of investigational product(s) and trial-related materials. Allows tracking of product batch, review of shipping conditions, and accountability · · · N/A Certificate(s) of analysis To document identity, purity, and N/A N/A
Essential_Documents_for_Conduct_of_Clinical_Trial_Checklist.docx