instructions provided to the subjects Instructions for handling of To document instructions X X needed to ensure proper Investigational Product(s) and storage, packaging, trial-related materials and any dispensing and disposition of updates investigational products and (If not included in Protocol or trial-related materials Investigator’s Brochure) Shipping records for X X To document shipment dates, batch numbers and method of Investigational Product(s) and shipment of investigational trial-related materials and any product(s) and trial-related updates* materials. Allows tracking of product batch, review of shipping conditions, and accountability Certificate(s) of Analysis of To document identity, purity, X and strength of investigational Investigational Product(s) shipped product(s) to be used in the including Certificates of Analysis trial for new batches and QP release Proof of Investigational Product(s) To document that the required X X storage conditions of the storage condition monitoring* Investigational Product(s) are maintained at site. Note that this is especially important where storage conditions vary from normal practice, e.g. use of refrigerator/freezer. Investigational Product(s) To document that the X X investigational product(s) have accountability at site * been used according to the protocol. To documents the
instructions provided to the subjects 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. Note that this is especially important where storage conditions vary from normal practice, e.g. use of refrigerator/freezer. X X Investigational Product(s) accountability at site * To document that the investigational product(s) have been used according to the protocol. To documents the X X
UoB-CLN-QCD-002-Essential-Document-Checklist-CTIMPs-v--1-0-dd---15-Aug-2---.docx