ISCT Example: Source Document Review Requirements General comments: 1. Adding it to personnel log or role delegation log as a QI or SI responsibility can’t hurt 2. This is sample of how a protocol would read 3. Also a sample of how labs should be reviewed for e and paper version Measure Record on Annotate as Annotate as CS CRF/eCRF CS or NCS or NCS in source on CRF documents Hb 3 3 ✓ ✓ ANC 3 3 ✓ ✓ Platelets 3 3 ✓ ✓ Other heme 1 2 3 ✓ values AST 3 3 ✓ ✓ Other LFTs 1 2 3 ✓ 1. Only if clinically indicated or centre practice 2. Only if considered clinically significant (i.e. requiring dose modification or resulting in symptoms) and related to protocol therapy; [depending on trial management may add as a lab value or as an adverse event] 3. Not required for this protocol. For labs required by the protocol causality will not be reported but incidence by arm reported CS = clinically signficicant: NCS = Not clinically signficiant
ISCT Example: Source Document Review Requirements General comments: 1. Adding it to personnel log or role delegation log as a QI or SI responsibility can’t hurt 2. This is sample of how a protocol would read 3. Also a sample of how labs should be reviewed for e and paper version Measure Record on CRF/eCRF Annotate as CS or NCS on CRF Annotate as CS or NCS in source documents Hb ✓ ✓ 3 3 ANC ✓ ✓ 3 3 Platelets ✓ ✓ 3 3 Other heme values 1 2 3 ✓ AST ✓ ✓ 3 3 Other LFTs 1 2 3 ✓ 1. Only if clinically indicated or centre practice 2. Only if considered clinically significant (i.e. requiring dose modification or resulting in symptoms) and related to protocol therapy; [depending on trial management may add as a lab value or as an adverse event] 3. Not required for this protocol. For labs required by the protocol causality will not be reported but incidence by arm reported CS = clinically signficicant: NCS = Not clinically signficiant
ISCT-Source-Document-Review-Requirements.docx