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Full Annotations

What Does It Do?

The Metadata tool can quickly add those SDTM domain and 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 domain names, domain labels, 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-full.png

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

  • Ensure the Multiple option is selected under the Domain Scope field.

  • Also, ensure the Stacked option is NOT selected under the Domain Orientation field.

  • IMPORTANT: Selecting the Stacked option, allows the user to annotate a domain labels and variables from multiple domains if and only if a domain name column exists on the same worksheet as the variable column. For example purposes only, the option will NOT be selected.

  • Click OK to continue, another window will appear.

annotations-annotate-window-full.png

  • The Domain Name field represents the parent domain of the variables but since Multiple was selected earlier this field will be disabled.

  • The Domain Label field represents the label of the parent domain in question but since Multiple was selected earlier this field will be disabled.

  • The Origin Worksheet field represents the domain's worksheet containing the list of variables which will be annotated and the corresponding case report page numbers, e.g., VLM.DS but since Multiple was selected earlier this field will be disabled.

  • 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, simply ensure Value Level Annotations is selected, then select the applicable Value Level Worksheet from the drop down list. For example purposes only, this option will NOT be selected.

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

  • 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. Click the field to open the folder selection dialogue.

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

  • 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.

  • IMPORTANT: When the Value Level Annotations option was selected, further prompts will appear ensuring the process annotates the parameter values, e.g., GLUC, HCT, WBC, etc. For example purposes, this Value Level Annotations option was NOT selected.

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

Fully Annotated Case Report Form (CRF)

  • IMPORTANT: The image above includes parameter values which only appear when Value Level Annotations button was clicked.

  • 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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