Objective: Generate SDTM data for submission using Mapper, specifically the LB domain.

Important: This tutorial assumes the user is already familiar with Mapper, how to create mappings and mapping domains, and the general functionality of Mapper.

Permissions: Requires the Mapper privilege.

Instructions

1. When creating the SDTM Mapping, it’s crucial to include the desired Standard and Controlled Terminology, since Mapper will use these libraries to facilitate the creation of the SDTM datasets.
2. Create the new domain, in this case LB, and notice when the name is entered the description automatically populates based on the standard that was selected for the Mapping.
3. Click Save and the transformation layout opens.
4. From the Data Stores on the left, drag the desired domain onto the grid, in this case LB_CHEM. The lower section of the window displays a preview of the first twenty-five records of the selected transformation layer, and notice the data is displaying in horizontal format.
   

   Tip: Within the preview section toolbar, click the Show Standard Variables button to see which variables are expected, but missing. Click the Show Data button to return to data preview.

5. To convert it to vertical format, apply an Unpivot transformation.
6. From the properties panel, click the ellipses for Unpivot Columns, and the Edit Pivot window opens.
7. Determine which key columns will uniquely identify the new record, and drag them into the Key Columns area. In this case SUBJECT, SITE, SITENUMBER, LBDAT, and LBTIM.
8. Choose which columns to unpivot, and drag them into the Variables area to add the variable name and its value. In this case, GLUCOSE, BUN, CREAT, SODIUM, and POTAS.
9. To include any additional values for the variable added, such as the units, click the Add Value Series button and drag those values into the value series. In this case, GLUCOSE_UN, BUN_UN, CREAT_UN, SODIUM_UN, and POTAS_UN.
10. Click Save.
11. To rename the variable and value columns, add a Variable transformation.
12. From the domain properties panel, click the ellipses for Variables, and the Edit Variables window opens.
    

    Tip: For column renaming, you can double-click the column headers directly and rename from there.

13. Enter the New Names for the variable and values columns you created. Optionally, you can also change any data types or hide variables as needed. In this case, LBTESTCD, LBORRES, and LBORRESU.
    

    Note: The system will recommend variable names based on the Standard selected for the Mapping and domain.

14. Click Save.
15. To merge data from other domains, add a union transformation. In this case, LB_HEME.
16. Add an Unpivot transformation, and repeat steps 6-10. In this case, WBC, RBC, HGB, HCT, and PLATELET + WBC_UN, RBC_UN, HGB_UN, HCT_UN, and PLATELET_UN.
17. Add a Variables transformation, and repeat steps 11-14.
18. Add an additional transformation you might need, such as a Join for a table of lookup values for standard names, units, or calculations that you can use in your logic, or SQL for more advanced transformations.
19. To finalize the mapping, click Save.
    

    Tip: The Report button provides you with a readable document of all the transformations that were made that can be given to an auditor if necessary.