Mapping Casebook Variables


The same Items and Event Dates are often referenced in multiple rule expressions. You can make it easier to access those objects by assigning them to a casebook variable. You can then reference these variables, instead of their lengthier identifiers, when writing rule expressions in the Rule Editor and when creating comparison rules.

Prerequisites

The Casebook Variables feature is only available in Studies created after the 20R2 (August 2020) release. These studies use version 2 of the CDMS data model. Contact your Veeva Services representative for details.


The following permissions are required to perform the actions described below.

Users with the CDMS Study Designer standard role can perform the actions described below. If your organization uses custom Study Roles, your role must grant the following permissions:

Type Permission Label Controls
Standard Tab Studio Tab

Ability to access the Studio tab

Functional Permission Design Study

Ability to create study design definitions and a study schedule from Studio

If your Study contains restricted data, you must have the Restricted Data Access permission to view it.

Learn more about Study Roles.


Accessing Casebook Variables

To access casebook variables, navigate to your Study in Studio. Then, in the Navigation panel, click Casebook Variables.

Select Casebook Variables in the Navigation panel

Standard Casebook Variables

Vault CDMS includes the following standard casebook variables:

Variable Name Variable Label
birth_date Birth Date
enrolled_date Enrolled Date
informed_consent_date Informed Consent Date
randomization_date Randomization Date
study_treatment_start_date Study Treatment Start Date
study_treatment_end_date Study Treatment End Date
termination_date Termination Date
withdrawn_date Withdrawn Date

In the current release, the ability to create custom variables is unavailable. You can use #define statements in your rule expressions to easily reference specific objects.

How to Map a Variable to a Value

You can map (assign) certain Event Dates and Items to these variables. Note that you can’t map to an Event Date or Item associated with a repeating Event Group, Form or Item Group. If any part of the event date or item’s identifier is repeating, the event date or item is unavailable for use with casebook variables.

To map a variable to a value (either an Item or an Event Date):

  1. Navigate to Studio > Casebook Variables for your study.
  2. Locate the row of the casebook variable you want to map.
  3. Select a Data Type. Select a Data Type

  4. Click into the FIELD_NAME field.
  5. In the Study Reference panel, select Item or Event Date.
  6. Begin typing the Name of the Event Definition or Item Definition.
  7. In the drop-down, select the Event or Item you want to map the variable to. For events, this maps to the Event Date of the event.
  8. Vault saves your changes as you go.

When finished, you can begin using your casebook variable in rule expressions or in the date comparison configurator.