updates test(s), and support reliability 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 Where applicable identification of retained tissue samples (if any) samples if assays need to be repeated Instructions for handling To document instructions X X Where applicable needed to ensure proper related materials and any updates storage, packaging, (If not included in Protocol) dispensing and disposition of study-related materials Shipping records for study-related X X Where applicable To document shipment dates, batch numbers and method of materials and any updates* shipment of study-related materials. Allows tracking of product batch, review of shipping conditions, and accountability Certificate(s) of Analysis of To document identity, purity, X Where applicable and strength of study materials Investigational Product(s) shipped to be used in the study including Certificates of Analysis for new batches Proof of storage condition To document that the required X X Where applicable storage conditions of the study monitoring* materials are maintained at site. Note that this is especially
updates certification or accreditation or established quality control and/or external quality assessment or - other validation (where required) test(s), and support reliability of results 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 Where applicable Instructions for handling materials and any updates (If not included in Protocol) To document instructions needed to ensure proper storage, packaging, dispensing and disposition of study-related materials X X Where applicable Shipping records for study-related materials and any updates* To document shipment dates, batch numbers and method of shipment of study-related materials. Allows tracking of product batch, review of shipping conditions, and accountability X X Where applicable Certificate(s) of Analysis of Investigational Product(s) shipped including Certificates of Analysis for new batches To document identity, purity, and strength of study materials to be used in the study X Where applicable Proof of storage condition monitoring* To document that the required storage conditions of the study materials are maintained at site. Note that this is especially X X Where applicable related
Essential-Document-Checklist-non-CTIMPs-v--1.docx