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];
Origin ID : C115525;
UMLS CUI : C3898686;
- Semantic type(s)
- concept_is_in_subset