Modify a library clinical data model

1. Click the Navigation icon at the top of any page and then click Library.

2. Select the project (or whatever study categories are called in your company) that includes the model.

3. Under Filter Library Data Models:, enter part or all of the model name and press Enter. The system lists all models whose name contains the string you typed.

4. Select the model you want, either by clicking it or by using the Down arrow and then pressing Enter.

5. Click Check Out near the top of the page. The system creates a new version of the model.

6. Make changes. If you have the required privileges, you can add, modify, or delete:

   Note:

   Follow all instructions except navigating to Study Configuration. You can modify these clinical data models in the library.

   • Tables by clicking the appropriate icon and making the changes. Follow instructions in Add tables except work in the Library page.

   • Columns in a table by selecting the table in the upper pane and clicking the appropriate icon in the Columns tab and making the changes. Follow instructions in Add columns to a table manually except work in the Library page.

   • Constraints in a table by selecting the table in the upper pane and clicking the appropriate icon in the Constraints tab and making the changes. Follow instructions in Add constraints to tables except work in the Library page. A primary key is required.

   • Blinding attribute values: Follow instructions in Set up data blinding in tables except work in the Library page.

   • Data Processing attribute value: Follow instructions in Set up Unit of Work data processing for tables except work in the Library page.

   • SDTM variable associations: Follow instructions in Use SDTM identifiers to support important functionality except work in the Library page.

   • Validation status: You can upgrade the validation status of a library model to indicate that it is ready for use, but it has no effect.

7. Check the status. Make sure it is installable before you check it in. A model is not installable if any of its tables are not installable. A table is not installable if it has no columns.

8. Check in the model by clicking Check In near the top of the page.

9. To test the library model, navigate to a study in the Study Configuration page and create a study model from the library model, then install it. Check the install log file. If there are any problems, fix them in the library model, upgrade the study model, reinstall, and check the log file again.

10. To upgrade a study model to the new version of the library model, check out the study model and click the Upgrade from Library Model icon.