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Variable Annotations

What Does It Do?

The Metadata tool can quickly add those SDTM variable annotations directly to your pdf based Case Report Form (CRF) in seconds, no manual text box drawing needed.

What Do You Need?

  • A list of SDTM variable names and labels and their corresponding CRF page number..

  • A blank or previously annotated Case Report Form (CRF) in the .pdf format.

Guide

  • Open Microsoft Excel.

  • Navigate to the Metadata ribbon.

  • Locate the Annotations section of the ribbon.

Ribbon - Annotations.png

  • Click the SDTM Variables button in the Annotations section.

  • A prompt will appear.

annotation-type-window-variable.png

  • Ensure the Variable option is selected under the Annotation Type field. 

  • Also, for example purposes only ensure the Single option is selected under the Domain Scope field.

  • IMPORTANT: Selecting Multiple here, ensures all domains found within the specification will be annotated, for example purposes only, a single domain's variables will be annotated.

  • Click OK to continue, another window will appear.

annotations-annotate-window-variable.png

  • The Domain Name field represents the domain of the variables.

  • The Origin Worksheet field represents the worksheet containing the list of variables which will be annotated and the corresponding case report page numbers, e.g., the worksheet VLM.DS.

  • The Value Level Annotations button allows the user to also include the parameter level annotations e.g., “LB.LBORES when LB.LBTESTCD=GLUC”. If the user wishes to do this. If so, simply ensure the Value Level Annotations button is selected, then select the applicable Value Level Worksheet from the drop down list. For example purposes, this option will NOT be selected, however see the full annotations page for an example.

  • The Case Report Form (.pdf) field will contain the case report form file itself. Simply click the field to open the file selection dialogue.

  • IMPORTANT: This process does NOT impact any existing annotations and can be repeatedly re-run if required.

  • The Output Directory by default, will auto-populated once a case report form (.pdf) was selected, the default Output Directory will be the same folder as the case report form file itself. Simply click the field to open the folder selection dialogue.

  • Click OK to continue.

  • Here the user needs to select the relevant ranges.

  • The Variable Range represents the column which holds the variable names, e.g., STUDYID, USUBJID, etc.

  • The Origin Range represents the column which holds the case report form page numbers.

  • IMPORTANT: when applicable, separate multiple case report form page numbers with a single space.

  • Click OK to continue.

  • A prompt will appear asking the user if they wish to open the newly annotated case report form, clicking Yes opens the annotated file.

Variable-Level Annotated Case Report Form (CRF)

  • The newly annotated file will be named Annotated CRFYYYY-MM-DDTHHMMSS.pdf. Where YYYY-MM-DDTHHMMSS represents the date and time the annotation process was run.

  • IMPORTANT: The process can be re-run with no impact to existing annotations, additionally, due to the output naming convention, any previously produced file will not be overwritten, instead a new annotated file is created after each run.

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