Create a library clinical data model

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

2. In the Library Data Models tab, select a study category (Therapeutic Area, Project, or whatever study categories are called in your company) from the drop-down list.

   The clinical data model will be available to studies in this category.

3. Click the Add icon. The Add Library Data Model window appears.

4. Enter a name and description for the model. See Naming restrictions for restrictions.

5. Under Select from source select one of the following:

   • None to define tables and column manually.
   • Load from file to create tables by uploading files. The system can create tables from zipped SAS datasets, SAS transport (CPort or XPort) files, or a .zip file that contains one or more text metadata (.mdd) files. Metadata files are the only way to automatically create tables with constraints and blinding attributes set; see Required syntax for metadata files.

     Browse to the file.

6. Click OK.

   Note:

   You must create a primary key for each table. Follow instructions in Add constraints to tables except work in the Library page.

7. If you are creating the tables manually, follow instructions in Add tables except work in the Library page. Complete the table specifications manually:

   • Each table must have a primary key. Follow instructions in Add constraints to tables.
   • Associate SDTM variables with columns whenever possible to enable full functionality in DMW. Follow instructions in Use SDTM identifiers to support important functionality except work in the Library page.
   • Follow instructions in Set up data blinding in tables except work in the Library page.
   • Follow instructions in Set up Unit of Work data processing for tables except work in the Library page.
   • If you are using Oracle Thesaurus Management System (TMS) as your coding system, see Map columns to data to be derived from TMS.

8. Check the status. Make sure it has a status of Installable before you check it in. A model is not installable if it does not have any tables or if any of its tables are not installable. A table is not installable if it has no columns.

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

10. 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.