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ADaM / Analysis Specifications

What Does It Do?

The Metadata tool can create ADaM or Analysis specifications directly from the CDISC documentation in seconds.

What Do You Need?

  • Any version of the ADaM CDISC Model.

  • A blank or custom Microsoft Excel file.

Guide

  • ​IMPORTANT: Unlike the SDTM specification creation process, the analysis specification creation process requires a template workbook. This is because the template defines the basic structure of the three common analysis data structures, including the basic data structure [BDS], intervention occurrence dataset [OCCDS.TRT] and event occurrence dataset structure [OCCDS.TERM].

  • 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.

Analysis (ADaM) CDISC Versions Window

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

  • *TIP* select the latest versions.

  • Click OK to continue, and the domain definition window will appear.

  • The user can now define the domain or domains they wish to import..

  • For example purposes four domains were defined:

    • OCCDS.TRT: ADCM.

    • OCCDS.TERM: ADDV & ADMH.

    • BDS: ADEG.

  • Click OK to continue the process.

  • After some time the process would have automatically exported the domains to the workbook on their own worksheets.

Analysis (ADaM) Specifications Exported Example

  • IMPORTANT: If the process is re-run, the domain definition window will display any previously defined domains in the window pane on the left.

  • If the process is re-run it will have no impact to any previously created worksheets.

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