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SDTM Specifications

What Does It Do?

The Metadata tool can create SDTM specifications directly from the CDISC documentation in seconds, no static metadata repository (MDR) required.

What Do You Need?

  • Any version of the CDISC Implementation Guide.

  • A blank or custom Microsoft Excel file.

Guide

  • Open Microsoft Excel.

  • Navigate to the Metadata ribbon.

  • ​Locate the Specifications section of the ribbon.

Ribbon - Specifications.png

  • Click the Create button in the Specifications section.

  • A prompt will appear.

CDISC Version Selection

  • Select SDTM from the Category then select the applicable CDISC versions, including the implementation guide version, model version and controlled terminology version.

  • *TIP* select the latest versions.

  • Click OK to continue, and a domain selection window will appear.

  • The user can now select the domain or domains they wish to import. Clicking OK will continue the process.

  • Note, subsequent runs will show previously selected domains in the lower table.

  • After some time a new prompt will appear, showing the variable level information applicable to the domain or domains selected.

specification-domain-selected.png

  • The user can choose to manually copy the tables, in full or in part. 

  • Alternatively the user can Export the contents directly into an Excel workbook, like so.

  • To export the domain and variable level information to an existing Excel template, click the Export button under the variable level table.

  • IMPORTANT: The process first exports the domain level (DLM) information (top box) then the variable level (VLM) information (bottom box).

  • First the DLM a prompt will appear.

specifications-export-dlm.png

  • If the process was run using a blank workbook, uncheck the Use Template option.

  • However, if the process was run using a template workbook, the Use Template option can be selected, and a Template Worksheet can be selected from the drop-down list, e.g., the worksheet named DLM.

  • Click to OK to begin the export process.

  • Next the VLM export prompt will appear.

specifications-export-vlm.png

  • If the process was run using a blank workbook, uncheck the Use Template option.

  • However, if the process was run using a template workbook, the Use Template option can be selected, and a Template Worksheet can be selected from the drop-down list, e.g., the worksheet named VLM.XX.

  • IMPORTANT: By default, when multiple domains were selected, each domain will be exported to their own worksheet, if the user wishes to export all domains to a single worksheet, uncheck the Split Domains option.

  • The Worksheet Prefix text will be added to each worksheet name added to the workbook.

  • Click to OK to begin the export process. 

  • IMPORTANT: If the user clicks Cancel at this stage, the DLM information will have been exported but the VLM information will not be exported.

​​

specifications-completion.png

  • After some time the above prompt will appear.

  • This indicates the process has finished, click Close on the window to close the specification creation window.

  • Review the exported domain level information first, e.g., check the DLM worksheet.

specifications-exported-dlm.png

  • The review the exported variable level worksheets. 

specifications-exported-vlm.png

  • The chosen domains have been successfully exported onto their own worksheets.

  • The process can be re-run again if required with no impact to previously exported domains.

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