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Metadataspec
Standards for CollectionStandards for TabulationStandards for Analysis 
  • Ask specific questions on the CRF (e.g., Temperature)
  • Collect data values using terminology (e.g., Y or N)
  • Name variables in the operational database (e.g., TEMP for the collection of vital sign data when a unique variable name must be created for each vital sign result).
  • Name domain datasets and variables in datasets when applicable.
  • Represent to dataset variable valuescollected, assigned, and derived values in datasets. 


  • To be added


Formats

Standards for tabulation and analysis require representation of dates and/or times, intervals of time, and durations of time in ISO 8601 format as defined by the International Organization for Standardization (ISO) (http://www.iso.org). The appropriate date and/or time ISO format must be used when specified. Additional ISO formats are referenced in this guide will be used as indicated in alignment with regulatory requirements.

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