4 Using Libraries

This section contains the following topics:

• "About Library Clinical Data Models"

• "Creating and Modifying Library Clinical Data Models"

• "Creating Code Lists"

See also "Setting Up Library and Study Categories".

About Library Clinical Data Models

Youcreate a library clinical data model directly in the library.

Libraries correspond to the categories—for example, therapeutic areas—that your company creates for the purpose of grouping studies and library data models. If you promote a study data model to the library, it is promoted to the library for the study's category. If you want to create standard data models that are appropriate for many study categories, you may want to create a category and study especially for that purpose and call them something like Generic or Standard. When you create a study data model from a library data model, you can select a data model from any library; see "Setting Up Library and Study Categories".

The system tracks all study clinical data models based on a library model. If the library model is modified, the system detects the study models based on previous library model versions and allows users to upgrade the study models or choose not to upgrade them.

When you create a study model based on a library model, you can modify the study copy as necessary, adding and deleting tables and columns. However, if you update your study copy to the latest library version you lose your changes.

Creating and Modifying Library Clinical Data Models

Clinical data models in a library are available for reuse in studies. When you modify a library model, any study models created from it can be updated to the latest version.

Creating a Library Clinical Data Model

To create a library clinical data model:

1. Click Library.

2. Click the Add icon (+) for Clinical Data Models. The Create Clinical Data Model window appears.

3. Enter a name and description for the model; see "Naming Objects" for restrictions.

4. Select the library in which the data model belongs. The label of this field as well as the options are configurable by your company; see "Setting Up Library and Study Categories".

5. Under Select from source select the source, if any:

   • 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 or with all blinding attributes set; see "Required Syntax for Table Metadata Text Files".

     Browse to the file.

6. Click OK.

   Notes:

   If you have not already created a primary key for every table in the model, you must do so; see "Adding Constraints to a Table".

7. 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.

Modifying Library Clinical Data Models

To modify a library model:

1. Go to the Library page and select a study category.

2. In the search field in the upper left, enter part or all of the model name and press Enter. The system lists all models whose name contains the string you typed.

3. Select the model you want, either by clicking on it or by using the down arrow and then pressing Enter.

4. To modify the model, click Check Out. The system creates a new version of the model for you to modify. This button is visible only if you have the privileges required to modify the model.

5. Make changes. If you have the required privileges, you can:

   • Add, modify, or delete tables by clicking on the appropriate icon and making the changes; see "Adding Tables to a Clinical Data Model".

   • Add, modify, or delete 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; see "Adding Columns to a Table".

   • Add, modify, or delete 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; see "Adding Constraints to a Table".

   • Update Validation Status The system displays this button only if you have the privileges required. Click this button to change the validation status (possible values are Development, Quality Control, or Production) or to upload a supporting document for the validation status change; see "Updating Validation Status".

6. 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.

Removing a Clinical Data Model

To delete a clinical data model, select it in the Clinical Data Model pane and click the red X Remove icon. You must have the Remove Model privilege to do this.

Creating Code Lists

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

1. In the Library page, select the Code Lists pane, then click the + icon.

2. Codelist Name: Enter a name for the code list that will help users know what it is.

3. Description: (Optional)

4. Select a therapeutic area or other library category. The code list will be available for use in study and library clinical data models in the same library.

5. Click OK.

Add Code Values Select the code list. In the Code List Values tab, click the + icon and enter:

1. Code: The code must be unique within the code list. The code is the allowed clinical data value; the string that the system tests for when columns are associated with the code list.

2. Code Value: You can use this as a more descriptive equivalent of the code. The system does not evaluate this value.

3. Click OK.

4. Repeat for each value.

5. Click Check In to make the code list available for use.

Code List Examples

Common code lists include:

• Code list YESNO with codes Y and N and code values Yes and No.

• Code list SEX with codes M and F and code values Male and Female.

Removing a Code List

To remove a code list, navigate to the Library, then Code Lists. Select the code list and click the Remove (red X) icon.

Note:

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