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Domain Annotations

What Does It Do?

The Metadata tool can quickly add those SDTM domain 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 domain 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-domain.png

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

  • The Multiple option will be selected under the Domain Scope by default.

  • Additionally. the Stacked option will be selected under the Domain Orientation field.

  • Click OK to continue, another window will appear.

annotations-annotate-window-domain.png

  • The Origin Worksheet field represents the worksheet containing the list of domains and their corresponding case report page numbers, e.g., DLM.

  • The Case Report Form (.pdf) field will contain the case report form file (.pdf) 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 from 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 Domain Range represents the column which holds the domain name, e.g., AE, DM, etc.

  • The Domain Label Range represents the column which holds the domain label, e.g., Adverse Events, Demographics, 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.

Domain-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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