Step 2: Create a New Casebook Version

Studio

Roles


During this step, a Study Designer will perform the following:

  • Create a new version of the Casebook Definition
  • Make design changes in Studio
  • Validate and publish the new casebook version
  • Export the Casebook Definition XML file for import into UAT/Training environments

How to Create a Casebook Version

When you first begin designing your study, Vault automatically creates a Casebook Definition record for your first version. After you have published this initial version, you’ll need to create new versions before making additional changes to your study design.

To create a new casebook version:

  1. In Studio, navigate to the Study you want to version.
  2. From the Actions menu, select Create New Version.
  3. Optional: Enter a Name for the version. This displays in the Studio Actions menu and in Tools > EDC Tools > Casebook Versions. If you do not enter a Name, Vault names your version with the Version Number.
  4. Select a Change Reason.
  5. Vault creates a new casebook version. This new version displays in Studio. Changes to this version will not affect existing subject casebooks.

You can see the current version number below the breadcrumb menu in Browse view.

Make Design Changes

Now, you can make changes to your design as needed within your new version. Note that certain changes are not allowed across versions (see a complete list here).

Validate & Publish

Before you can publish any version of a Casebook Definition, you must validate your study design. Vault EDC reviews your study design and configuration, and sends you a CSV with any errors that must be resolved prior to publishing.

To validate your Casebook Definition:

  1. In Studio, navigate to the Study that you want to validate.
  2. From the Actions menu, click to expand Casebook Versions.
  3. Select Validate.

    Validate action

  4. In the confirmation dialog, click Validate.
  5. Vault begins an asynchronous job to validate your casebook. When complete, Vault sends you an email notification with a link to download a CSV file listing any errors and warnings.

Once you complete your updates and resolve any validation errors, you can publish your casebook version.

Note that the Publish Version action does not display until you validate the casebook version.

To publish a casebook version:

  1. In Studio, navigate to the Study for which you want to publish a casebook version.
  2. From the Actions menu, click to expand Casebook Versions.
  3. Select Publish Version.
  4. Vault publishes your casebook version. Vault EDC makes all definition objects for that version , except for rules, read-only.

You can easily determine whether or not your current version is published from Browse view. When your most recent casebook version is published, Vault displays a Lock icon next to the Studio Actions menu. Once you create a newer version, Vault displays an Unlocked icon.

Studio

Roles