PropertyValue
?:definition
  • 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]
?:hasCUIAnnotation
?:hasGeneratedBy
?:type

Metadata

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