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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 data collection guidance and best practices.
  • Guidance for development, management, and use of case report forms (CRFs) irrespective of the inclusion of collected data in subsequent tabulation datasets.

The TIG supports 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. 

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