Record of retained body fluids/ To document location and X X tissue samples (if any) identification of retained samples if assays need to be repeated Sample of attached to To document compliance with X Investigational Product applicable labelling regulations container(s) and appropriateness of instructions provided to the subjects Instructions for handling of To document instructions needed X X Investigational Product(s) and to ensure proper storage, trial-related materials and any packaging, dispensing and updates disposition of investigational products and trial-related (If not included in Protocol or materials Investigator’s Brochure) Shipping records for To document shipment dates, X X Investigational Product(s) and batch numbers and method of trial-related materials and any shipment of investigational updates* product(s) and trial-related materials. Allows tracking of product batch, review of shipping conditions, and accountability Certificate(s) of Analysis of To document identity, purity, and X Investigational Product(s) shipped strength of investigational including Certificates of Analysis product(s) to be used in the trial for new batches and QP release Proof of Investigational Product(s) To document that the required X X storage condition monitoring* storage conditions of the Investigational Product(s) are maintained at site.
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 attached to Investigational Product container(s) To document compliance with applicable labelling regulations and appropriateness of instructions provided to the subjects X Instructions for handling of Investigational Product(s) and trial-related materials and any updates (If not included in Protocol or Investigator’s Brochure) To document instructions needed to ensure proper storage, packaging, dispensing and disposition of investigational products and trial-related materials X X Shipping records for Investigational Product(s) and trial-related materials and any updates* 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 X X Certificate(s) of Analysis of Investigational Product(s) shipped including Certificates of Analysis for new batches and QP release To document identity, purity, and strength of investigational product(s) to be used in the trial X Proof of Investigational Product(s) storage condition monitoring* To document that the required storage conditions of the Investigational Product(s) are maintained at site. X X
UoB-CLN-ESD-QCD-001-Essential-Document-Checklist-CTIMPs-v.-2.0-dd01-Mar-2016.docx