Analysis Specifications
Metadata → Specifications → Analysis (ADaM)
This process creates the basis for your CDISC ADaM analysis datasets directly from the CDISC standards, no fixed template, no metadaa repository, no human error..
The Metadata tool can create ADaM or Analysis specifications directly from the CDISC documentation in seconds.
Any version of the ADaM CDISC Model.
A blank or custom Microsoft Excel file.
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 CDISC section of the ribbon.
Click the Create Specifications drop down then the Create Specifications button.
A prompt will appear.
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.
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.