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The CDASH Model establishes a standard way to collect data across studies. Guidance in this section implements the CDASH Model and provides:

  • Basic standards and best practices for data collection.
  • Guidance for development, management, and use of case report forms (CRFs).

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 the table below is used throughout this section and should be interpreted as specified.

Metadataspec
NumLanguageInterpretation
1CRF
  • Refers to both paper CRFs and electronic CRFs (eCRFs) unless otherwise specified.
2Fields
  • Refers to where data is collected in a CRF.
3Variable
  • Refers to where data is 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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