Collection metadata in this guide are instructions for implementing the CDASH Model
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to develop CRFs and the underlying database or other data collection structure.
Collection metadata for the TIG are provided in Section 2.7.6,
Metadata for Individual Health.
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As the following guidance Guidance in this section describes how to read collection metadata
provided in Section 2.7.6
, it is recommended that . Implementers should refer to Section 2.7.6
is referenced in tandem with when reading this guidance
to provide context and examples.
Collection metadata will be used with all guidance in this section and are organized with 1 set of metadata per domain.All collection metadata begin with a description of the domain.
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A metadata table follows to describe data collection fields and their attributes. Assumptions for the domain are also provided to further guide implementation. Metadata tables are structured to present 1 or more rows for each data collection field with columns to describe attributes for each field. More than 1 row will be present in a metadata table when data collection for a field can be performed using different scenarios/options. Multiple data collection options may also be provided in single cell within a row for a field with each option separated by a semicolon.
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