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The CDASH Model establishes a standard way to collect data across studies. Guidance in this section implements the CDASH Model for the TIG Product Impact on Individual Health use case and provides:

  • Basic basic data collection guidance and best practices.;
  • Guidance guidance for developmentdeveloping, managementmanaging, and use of case report forms (CRFs) using CRFs, irrespective of the inclusion of collected data in subsequent tabulation datasets.; and
  • Guidance guidance for mapping data collected via CRFs to tabulation datasets be used to as applicable with guidance in Section 2.8, Standards for Tabulation.

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