CDISC Export

Specify a file outside of Phoenix as the source

Specify a Phoenix object as the source

Note:    The images in this section show the SDTM Export Wizard. The options are identical to those in the SEND Export Wizard.

Select File > CDISC > SDTM > Export for SDTM formatted datasets.

Or

Select File > CDISC > SEND > Export for SEND formatted datasets.

SdtmExportWizard

Clear the Select checkbox beside a domain to exclude it from the export.

Specify a file outside of Phoenix as the source

1.  Click in the Datasource cell beside the domain.

2.  Select File System and press OK.

3.  In the file browser, locate and select the .xpt file and press Select.

4.  Press Finish to export the data.

Upon export, the original .xpt file from the file system is overwritten. Because of this, there is no need to do any mapping for the domain.

Specify a Phoenix object as the source

1.  Select Phoenix Project and press OK.

2.  Select a worksheet in the Select Object dialog and press Select.

Each domain has its own set of study variables that must be mapped. Map columns in a dataset to domain variables.

3.  If a map file exists of the selected domains and data sources, press Load Map to load the file.

Otherwise, click >> to proceed with the mapping.

The Variable column contains the CDISC variable names. The column headers in the data source are not required to match the variable names.

DMdomainmappanel

Note:    When exporting a PP domain, an additional checkbox is shown above the table, Include RELREC. Turn on to include related records. See “Exporting related records” for more information.

4.  In the Filter field, type a column name then a condition to filter the current domain's input.

For example, if data is retrieved from Certara Integral that contains dosing and sample data, entering Type=‘Dose’ in the Filter field only exports the dosing data. Note that the Filter field is case sensitive.

5.  Use the Map Column menus to select a column in the data source to map each CDISC variable.

6.  Check the Use Column Unit box to move units in a column header to their own column during export.

7.  In the Static Value field, enter a static value for a CDISC variable.

Note that the Map Column selection supersedes any static value.

8.  Check the Sequence box if a column contains the output order or the treatment sequence in a crossover study.

9.  Click >> to continue mapping for each selected domain.

10.  Optionally save mappings to an XML file for future use once mapping is complete by clicking Save Map.

Every selection in the export wizard, including domains, static values, etc., is saved in the map file.

11.  To export the data, press Finish and, in the Browse for Folder dialog, select an export directory.

The exported data is placed in a directory with date and time stamps included in the name. A message is displayed when the export is complete. If a required field is missing, the export continues but an alert is presented.


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