Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

Metadata tables are structured to present one or more rows for each data collection field withcolumns to describe attributes for each field. Metadata tables contain more More than one row when... Multiple rows for are present  When multiple options are will be present in the metadata table when there is more than one data collection scenario for a data collection field. When more than one options are applicable contained in a single cell, the options are separated by a semicolon.

Each column in a metadata primarily guides one of the following aspects of data collection: At the highest-level columns describe: high-level purpose of columns

  • CRF and System Design to guide development of the CRF(s) and the underlying database structure in conformance with the standard.
  • Tabulation Dataset Generation to guide development of programs to generate tabulation datasets from compliant data. link between CDASH and SDTM
  • Data Collection Field Implementation to guide use of fields and facilitate creation of study-level documentation to support expected field completion.

...