3 Create libraries of codelists and clinical data models

Each study group (for example, therapeutic area or project) has a library where you can create standard clinical data models and codelists. These models and codelists are available for use in all studies, but you can use the library to store models and codelists that are appropriate for each study group.

If you want a library of models and codelists that are suitable for use in all studies, your administrator can create a "study group" for that purpose.

• Create a codelist
  
• Create a library clinical data model
  

Create a codelist

Codelists specify a list of valid values that you can associate with a table column.

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

2. Select the Codelists tab.

3. Select a project (or whatever study groupings are called in your company) in which to create the codelist.

   Tip:

   Selecting a grouping is required and can help users find the codelist. But codelists in any grouping can be used in any study.

4. Click the Add or Modify icon. (If you are modifying the codelist, you must first check it out.)

   Tip:

   Modifying a codelist creates a new version of it. When you assign the codelist to a column, the column uses the current version. Columns that already use the old version will continue to do so unless you explicitly modify the column.

   • If you want to change all columns to the new version, modify the codelist.

   • If you want to be able to assign either version to a column, create a whole new codelist with the modified list of values.

5. Codelist Name Enter a name.

6. Description: (Optional) Enter a description such as its values to help users decide if this is the codelist they need.

7. Click OK.

• Add code values
  
• Remove a codelist
  

Add code values

1. Select the codelist. In the Codelist Values tab, click the Add or Modify Value icon and enter:

2. Code: The allowed clinical data value.

3. Code Value: This is the value displayed in the user interface. The system does not evaluate this value.

4. Click OK.

5. Repeat for each value.

6. Click Check In to make the codelist available for use.

Remove a codelist

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

2. Select the Codelists tab.

3. Select a project (or whatever study categories are called in your company).

4. Select the codelist.

5. Click Check Out if it is not already checked out.

6. Click the Remove icon.

Note:

You cannot remove a codelist if it is associated with a table column.

Create a library clinical data model

You can maintain a library of standard clinical data models and create study clinical data models based on and linked to a library model. When you update the library model, the system displays an Upgrade button in the study model and you can click it to update the study model to the new library version. Any changes you have made to the study model are lost.

• Create a library clinical data model
  
• Modify a library clinical data model
  
• Delete a library clinical data model
  

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.

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.

Delete a library clinical data model

To delete a clinical data model, select it in the Library Data Model pane and You must have the Remove Model privilege.

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 a model, either by clicking it or by using the Down arrow and then pressing Enter.

5. Click Check Out if it is not already checked out.

6. Click the Delete Clinical Data Model icon.

Note:

It is possible to delete a library model that has been used in a study. This has no effect on the study model.