authorised to make entries and/or corrections on CRFs This may be combined with the delegation of responsibilities log. Delegation of responsibilities log To document what duties have X X been delegated by the site PI to site staff. This may be combined with the Signature Sheet. Normal for To document normal values X X and/or ranges of the tests medical/laboratory/technical procedure(s) and/or test(s) included in the Protocol, including any updates Medical/laboratory/technical To document competence of X X facility to perform required procedures/tests, including any test(s), and support reliability updates of results certification or accreditation or established quality control and/or external quality assessment or - other validation (where required) Record of retained body fluids/ To document location and X X identification of retained tissue samples (if any) samples if assays need to be repeated Sample of label(s) attached to To document compliance with X applicable labelling regulations Investigational Product and appropriateness of container(s)
authorised to make entries and/or corrections on CRFs This may be combined with the delegation of responsibilities log. Delegation of responsibilities log To document what duties have been delegated by the site PI to site staff. This may be combined with the Signature Sheet. X X Normal for medical/laboratory/technical procedure(s) and/or test(s) included in the Protocol, including any updates To document normal values and/or ranges of the tests X X Medical/laboratory/technical procedures/tests, including any updates certification or accreditation or established quality control and/or external quality assessment or - other validation (where required) To document competence of facility to perform required test(s), and support reliability of results X X Record of retained body fluids/ tissue samples (if any) To document location and identification of retained samples if assays need to be repeated X X Sample of label(s) attached to Investigational Product container(s) To document compliance with applicable labelling regulations and appropriateness of X
UoB-CLN-QCD-002-Essential-Document-Checklist-CTIMPs-v--1-0-dd---15-Aug-2---.docx