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, 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.
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.
There are three (3) primary stages to the casebook versioning process:
1. Initial Version Designed, Published & Deployed
When a clinical programmer first creates a new study, Vault creates the first Casebook Definition record, and thusly the first version of that study design. The clinical programmer can then publish that version, making the initial version available for deployment to sites.
The next two stages only apply if you make a change to your study’s design after publishing the initial version.
2. Design & Publish 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 publish that version again. Once that version is published, it is available for deployment and 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 environment to the destination environment. This will make the new version available for an amendment in the destination environment.
For studies using automated deployments, this is done 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 version is available in the destination environment , a study administrator or data manager can use EDC Tools to run either a retrospective or, if enabled, prospective casebook amendment, to make the updated version available to sites. See details about each type of casebook amendment below.
A casebook amendment is when an administrator promotes a site to use a new, updated version of the Casebook Definition. You can choose where and how the promotion begins within each casebook by the amendment type: retrospective and, if enabled, prospective. Sponsors can use amendments to make changes mid-study, including updates to study protocol, resolving existing design errors, and updating input or output requirements.
Prospective Casebook Amendments
A prospective casebook amendment is a study design revision that begins “this point forward”. Data managers can use prospective casebook amendments to apply a change to all existing Casebooks, starting at the chosen Start Event, without removing or updating any previously collected data.
Retrospective Casebook 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.
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.
Prospective Amendment: Add New Brands of Baby Formula to a Codelist
Bryce Pharma is sponsoring a study with infant subjects. At each visit, parents report the brand name of the formula they feed their baby. Over the course of the study, there were two new brands of formula on the market. The sponsor can add those new formula brand names to the Formula Name codelist, so that sites can record when parents are using a new brand.
Lateef, a clinical programmer, creates a new version, adds those new values to the Formula Name codelist, and then publishes the new Casebook Definition version. Amir, the lead data manager on the Veeofen study, can then initiate a prospective casebook amendment from EDC Tools to update sites to the new version. Amir uses a prospective amendment because the new brands were not available when data was collected for previous forms. With the prospective amendment, Vault only adds the new Formula Name options to new forms after the Start Event and to any existing forms that have not had data collected.