REC favourable ethical opinion Fully signed IRAS form, UoB-CLN-CTM-SOP-001 REC favourable ethical UoB-CLN-ESD-SOP-001 opinion letter listing the approved document set Competent Authority authorisation (as Fully signed IRAS form, UoB-CLN-CTM-SOP-001 applicable) Clinical Trial Authorisation UoB-CLN-ESD-SOP-001 letter NHS permissions Fully signed IRAS form, UoB-CLN-CTM-SOP-001 R&D permission letter UoB-CLN-ESD-SOP-001 Any other required approvals, opinions Approval letters UoB-CLN-CTM-SOP-001 or permissions identification and UoB-CLN-ESD-SOP-001 application (e.g. GP practice approval, ARSAC, IRMER). CRF development CRF UoB-CLN-ESD-SOP-001 Statistical analysis plan development Statistical analysis plan UoB-CLN-STA-SOP-001 Database building for the collation of Database UoB-CLN-TSM-SOP-001 trial data
REC favourable ethical opinion Fully signed IRAS form, REC favourable ethical opinion letter listing the approved document set UoB-CLN-CTM-SOP-001 UoB-CLN-ESD-SOP-001 Competent Authority authorisation (as applicable) Fully signed IRAS form, Clinical Trial Authorisation letter UoB-CLN-CTM-SOP-001 UoB-CLN-ESD-SOP-001 NHS permissions Fully signed IRAS form, R&D permission letter UoB-CLN-CTM-SOP-001 UoB-CLN-ESD-SOP-001 Any other required approvals, opinions or permissions identification and application (e.g. GP practice approval, ARSAC, IRMER). Approval letters UoB-CLN-CTM-SOP-001 UoB-CLN-ESD-SOP-001 CRF development CRF UoB-CLN-ESD-SOP-001 Statistical analysis plan development Statistical analysis plan UoB-CLN-STA-SOP-001 Database building for the collation of trial data Database UoB-CLN-TSM-SOP-001