" /> Investigational Product Handling Instruction - CISMeF





Preferred Label : Investigational Product Handling Instruction;

NCIt related terms : IP Instructions for Handling; IP Instr Handl; Investigational Product Instructions for Handling;

NCIt definition : Documentation that describes the safe handling, storage, distribution, and return of unused investigational product (IP) during the entire study period, including transit to and from the sponsor's facility.;

Alternative definition : CareLex: Written instructions on how the investigational product (IP) should be handled during transit and stored upon arrival at the distribution center, depot, and/or trial site. Instructions address expectations for adequate and safe receipt, handling, storage, dispensing, retrieval of unused product from subjects, and return of unused IP to the sponsor (or their delegate). If appropriate to the trial, includes preparation of the IP leading to administration. [Adapted from TMF-RM];

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02/06/2024


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