PropertyValue
?:definition
  • A documented description clearly defining the end-to-end process for the ongoing safety evaluation for the investigational product (IP). May include but not limited to data to be collected, reporting objectives, and processes for a clinical trial. Plan may also include but is not limited to associated documents for quality management, safety database entry specifications and templates, and/or coding guidelines. [Adapted from TMF-RM]
?:hasCUIAnnotation
?:hasGeneratedBy
?:type

Metadata

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