" /> Clinical Trial Investigational Product Supply Plan Documentation - CISMeF





Preferred Label : Clinical Trial Investigational Product Supply Plan Documentation;

NCIt related terms : IP Supply Plan; IP Suppl Plan; Clinical Trial Material Distribution Plan; Trial Medication Plan; Investigational Product Supply Plan;

Alternative definition : CareLex: Written procedures to define supply management as it pertains to the investigational product (IP). Plan includes details regarding quantity of active, placebo, comparator, and/or rescue supplies needed to fulfill the requirements of the protocol over the life of the clinical trial. Plan also includes but is not limited to acceptable storage temperatures and conditions, storage times, reconstitution fluids and procedures, and devices for product infusion. [Adapted from TMF-RM]; CDISC: Documentation describing the supply management of the investigational product(s) for the clinical trial.;

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07/05/2025


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