Versions Compared

Old Version 53

changes.mady.by.user Christine Connolly

Saved on

compared with

New Version 54

changes.mady.by.user Christine Connolly

Saved on

Key

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

Domain specifications are instructions for implementation of implementing the CDISC SDTM to build datasets for representation of collected, assigned, or derived data. Domain specifications for the TIG are provided in the following sections:

...

All domain specifications begin with the expected name and record structure for the resulting dataset. A domain specification table follows to describe the domain's variables and their attributes. Assumptions specific to the domain are also provided to further guide implementation. Domain specification tables are structured to present one row for each variable with columns to describe expected attributes of the variable in resulting datasets. The order of variables in a domain specification table reflects the expected order of variables in the resulting dataset.


Metadata tables are instructions for implementing the CDASH model to develop CRFs and the underlying database or other data collection structure. Metadata tables for the TIG are provided in:

Metadata tables are organized with one table per domain and are structured to present one or more rows for each data collection field with columns to describe attributes for each field. More than one row 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 option is applicable in a single cell, semicolons are used to separate descreet options.

Each column in a metadata table provides guidance which focuses one or more of following aspects of data collection. 

  • 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.

The columns in a metadata table are: 








Metadata tables are organized by domain - specification naming

...