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The TIG standard directly addresses development of CRFs but does not formally address data collected via other sources. However, the principles and metadata presented can be applied to eSource (also known as "non-CRF") data, such as vendors' electronic data transfer standards and ePRO data structures, as applicable.

Language In practice, there is variety in language used to describe operational concepts used as part of data collection. for consistency language shown below is used throughout this section and should be interpreted as specified.

Metadataspec
NumLanguageInterpretationRefers to:
1CRF
  • Refers to both Both paper CRFs and electronic CRFs (eCRFs) unless otherwise specified.
2Data Collection Field(s)
  • Refers to data Data elements that are commonly on the CRF.
3Data Collection Variable(s)
  • Refers to data Data elements stored in an electronic data capture (EDC) system.  
4Mechanisms for data collection
  • Refers collectively to different approaches used to control how data are collected including tick boxes, checkboxes, radio buttons, and drop-down lists. 

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