Casebook Versioning Overview

Once a clinical programmer finishes designing a Study and its Casebook Definition, that Casebook Definition is the first casebook version. When changes are required for a study design, for example, a study amendment or a missed specification, a clinical programmer or study manager can create a new casebook version that includes the change. After they publish the casebook version and set it as the active version for sites, Vault uses the new version when creating any new Casebooks. A study manager can use the Casebook Versioning tab of their EDC Tools to update existing Casebooks to the new version. Not all changes to a study design require a new Casebook Version. Learn more about what changes require a new version and what changes are versionless.

Data Model

Vault EDC stores subject data within a Casebook object record. Each Subject has one Casebook per Study. Each Casebook contains the study schedule and data collection objects. As part of study design, a clinical programmer creates a Casebook Definition. The Casebook Definition, created in EDC Studio, contains all object definitions and their relationships for the Study. The Casebook Definition, and its child definitions, are the template from which Vault creates a Casebook. Each time you create a new version of the Casebook Definition, Vault updates the relationships between the Casebook Definition and all of its study design object definitions to the new version.

Build Number and Casebook Version

Vault CDMS tracks changes to the design of a study through the Build Number and the Casebook Version:

  • Build Number: After a study design has been deployed to a Test (TST) environment, the Build Number of the study design starts to increment. For each modified study design that is deployed, the Build Number increases.
  • Casebook Version: The Casebook Version tracks the versions of the Casebook Definition that are deployed to the Production (PRD) environment (published). After a study design is published the Casebook Version starts to increment. To make versioned changes to a study design, you must create a new Casebook Version. Learn more about what changes require a new Casebook Version and what changes are versionless..

Versioning Process

There are three (3) primary stages to the casebook versioning process:

1. Initial Version Designed, Deployed & Published

When a clinical programmer first creates a new study, Vault creates the first Casebook Definition record, which is the first version of that study design. The clinical programmer can then deploy that version and then publish it, after which the version can be enabled for sites.

The next two stages only apply if you make a change to your study’s design after publishing the initial version.

2. Design a New Version in Studio

After a need for a new version has been identified, the clinical programmer can create a new version of the Casebook Definition from Studio in their development environment. Within that version, they can make their design changes and then deploy that version to the TST environment again. Once that version is deployed, it is available for deployment to the production (PRD) environment (also called “publishing”) and for subsequent amendments.

Note that certain changes are not allowed across casebook versions to prevent errors during the amendment process.

3. Deploy the New Version to Destination Environments

A deployment administrator can now deploy the Study from the source TST environment to the destination PRD environment. This will make the new version available for an amendment in the destination PRD environment.

Deployment is performed from from EDC Tools. For studies using manual deployments, this done by exporting and importing the design in Studio.

4. Run an Amendment in EDC Tools

Once the new casebook version is available in the destination PRD environment it can be set as the active version for the site in EDC Tools. This will apply the new version to all new casebooks created by the site. A study administrator or lead data manager can use EDC Tools to run a retrospective amendment to apply the new Casebook Version to existing Casebooks. See details about casebook amendment below.

Casebook Amendments

A casebook amendment is when an administrator promotes a site to use a new, updated version of the Casebook Definition. Sponsors can use amendments to make changes mid-study, including updates to study protocol, resolving existing design errors, and updating input or output requirements. New Casebook Versions can be applied to existing Casebooks through retrospective amendments.

With retrospective casebook amendments, Vault updates all existing casebook data to reference the new version, modifying any previously collected data to comply with the new version. For example, if a new version removed the Secondary Baseline Visit form from the study, a retrospective casebook amendment would remove the Secondary Baseline Visit form from any existing Casebooks, even if the site already collected data for that form.

Known Issue: Vault does not include deleted records in Detail PDFs. Admins can view audit information related to deleted records using the Audit Trail Export job or from Admin > Logs > Object Record History.

Example Use Cases

The examples below each use one type of casebook amendment:

Retrospective Amendment: Initial Published Version Missing a Form

Teresa is a clinical programmer for the Deetoza study. Her team published the initial casebook version, and that casebook version is now available for sites to use. Teresa reviewed her study design specifications, and she noticed that the Deetoza study’s Casebook Definition is missing the Substance Use form definition.

Teresa can easily create a new casebook version and add this form. Teresa creates a second casebook version for the Deetoza study. She then creates the Substance Use form definition, its Item Group Definitions, and its Item Definitions. Once she verifies that the new casebook version meets her study specifications, she publishes the second casebook version.

Once the new casebook version is available, Tracy Lee, the study manager, can access the EDC Tools area to initiate a retrospective amendment, which adds the new Substance Use form to all current Casebooks, as well as any future casebooks at each site.

Versioned and Versionless Changes

Versioned changes are changes to elements of a study design including changes to objects related to casebooks, data collection, and the study schedule design. Versioned changes require the creation of a new casebook version and the execution of a casebook amendment to apply to existing casebooks.

Versionless changes are changes to how Vault processes and analyzes data within the study. Versionless changes do not require the creations of a new casebook version, and do not require a casebook amendment to apply to existing casebooks. Changes to the following elements of a study in Vault CDMS are versionless:

  • Rules (including univariate edit-checks like “Required” or “No Future Date”, and Progressive Display)
  • Form-to-Form Links (but not Item-to-Form Links)
  • Coding
  • Assessments
  • Protocol Deviations
  • Data Loader Configurations
  • Safety Configurations
  • Integration Configurations
  • Review Plans
  • Subject Groups
  • CDB

The first change between deployments regardless of whether the casebook version changes will still result in the build number being incremented.

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