Managing Casebook Versions & Amendments

Once a study designer publishes a casebook version in Studio, you can easily manage your casebook versions site-by-site in the EDC Tools > Casebook Versions.

• For details about publishing casebook versions, see Working with Casebook Versions in Studio.
• For more information about how casebook versioning works in Vault EDC, see Casebook Versioning Overview.

Accessing EDC Tools

To access the EDC Tools administration area, click the Tools tab in the primary navigation bar, and then click EDC Tools.

Casebook Versioning

Vault EDC’s casebook versioning feature allows studies to iterate on their designs. A study team can publish and use an initial version of the study, and then if changes are required during execution, they can amend the design with a new version.

Casebook Amendments

Whenever your sponsor makes a change to your study design, you can use casebook amendments to update your sites to use that new version.

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.

Navigating EDC Tools > Casebook Versions

In EDC Tools, you’ll manage your casebook versions from the Casebook Versions tab. Casebook Versions has three (3) subtabs:

• All Versions
• Active Versions by Site
• Amendment History

All Versions

From All Versions, you can view a list of all existing Casebook Definition versions for your Study. You can see the number of subjects and sites active on each version.

You can also compare two casebook versions in your Study or compare a casebook version to another Study, either in the current vault or another vault. This creates a comparison report Excel™ file. Learn more about comparing casebook versions.

Active Versions by Site

From Active Versions by Site, you can view a list of sites within your study, and what casebook version is currently assigned to each site. You can also initiate casebook amendments and transfer subjects from Active Versions by Site. Note that the amendment options do not display until more than one published version exists for your study.

Amendment History

From Amendment History, you can view a list of all past amendments within your study. You can use this subtab to review past amendments, including which Subjects and Sites were impacted, and view summary and log files for each amendment.

You can choose to group amendments by Site or None (the default grouping). When you group by Site, you can easily see the number of amendments and updated Subjects for each of your Sites.

Deploying to Sites

Once a study designer has published the initial version of your Casebook Definition, and, if applicable, imported it from a development to production vault, Vault automatically assigns the most recent, published version available to newly created sites.

For example, if you created two sites in January 2019, when there was only one published version of your study, those sites were automatically assigned to that first version. Since then, there were two more versions added to your study. When you create a new site, Vault automatically assigns the new site to the most recent version, Version 3.

As you add new versions to your Study, you will need to update the Active Version of your Sites. The Active Version is the version that Vault uses to create new Casebooks at that Site.

Update a Site’s Active Version

You can update the Active Version assigned to one Site, or you can assign the same Active Version to multiple Sites at once.

Update the Active Version for a Single Site

To update the Active Version of a single Site:

1. Navigate to your Study in EDC Tools.
2. Open Sites.
3. Click the Site Number of the Site you want to update. Vault opens the Edit Study Site dialog.
4. Select a new Active Version from the drop-down.
5. Click Save.

You can now run an amendment to update existing Casebooks at the site or subject level to the new casebook version.

Update the Active Version for Multiple Sites

To update the Active Version of multiple Sites:

1. Navigate to your Study in EDC Tools.
2. Open Sites.

3. Select Sites to update.

4. Optional: Select the All Sites checkbox in the header to select all Sites.

5. Click Set Active Version. Vault opens the Set Active Version dialog.

6. Select an Active Version from the drop-down.

7. Click Set Active Version.

8. Vault updates the Active Version for all selected Sites. From this point forward, all Casebooks created within these Sites will be based on the assigned Active Version.

You can now run an amendment to update existing Casebooks at the site or subject level to the new casebook version.

How to Initiate a Retrospective Amendment

Once a study designer has published a new version of your study, you can deploy it to sites using a retrospective casebook amendment. Note that Vault does not apply amendments to locked Casebooks or Forms. Frozen forms may become unfrozen if an amendment updates the form. If the amendment encounters a locked form, it skips the subject.

Vault automatically uses the first Event Group and Event in the study’s schedule to apply the new version. If you need an amendment to begin later in the schedule, contact Veeva Support.

To initiate a retrospective casebook amendment:

1. Navigate to your Study in EDC Tools.
2. Click Casebook Versions.
3. Click Active Versions by Site.
4. Select the Sites you want to move to the new version. You can choose one, some, or all of your Sites.
5. Click New Retrospective Amendment or select New Retrospective Amendment from the site’s Actions menu.
6. Select the Target Version. This is the new version that you are moving sites onto.
7. Set the scope of your amendment:
   • Select Update all subjects to update all subjects at the chosen sites.
   • Select Update specific subjects to select individual subjects to update. If you choose this option, Vault displays a list of subjects. Select each Subject that you want to receive the amendment.
8. Optional: To keep any existing, submitted forms in the Submitted status, select Leave as Submitted for Status for Changed Forms. Otherwise, leave this field as Set to In Progress. This sets the status of any modified forms as In Progress Post Submit.
9. Click Run Now. Vault begins a job to apply your retrospective amendment to your sites. Rules must be run in a separate job after the retrospective amendment is complete. Vault sends you an email notification when the job is complete. You can view the job’s status and log from EDC Tools > Jobs.

When the job is finished, your amendment is applied. The new version is now the Active Version for all sites that you amended. Any new casebooks will reference that version. Existing casebooks have been promoted to the new version. Because retrospective amendments update collected data, Vault may create system-generated queries after the amendment for any data that doesn’t conform to the new version.

Note that retrospective amendment jobs can’t run for more than 24 hours. The number of casebooks that can be run per job is dependent on the size of the study.

Destructive Changes Not Allowed

Vault doesn’t allow amendments that contain destructive changes. A destructive change refers to the removal of an Event Group, Event, Form, Item Group, or Item from the study schedule or moving one of those components from one location in the schedule to another.

If you attempt to run an amendment containing a destructive change, the amendment will fail.

Vault first determines if there is a destructive change, then if there are any Casebooks with form data in any version. If there is form data, and the amendment contains a destructive change, the retrospective amendment fails, even if none of the data was in the selected source version or if any of the data would’ve been directly impacted by the targeted version.

The following study design changes between versions are allowed during a retrospective amendment:

Event Groups

• Changing Label, Description, External ID, Display Override Label, and help text
• Deletion
• Changing from repeating to non-repeating and non-repeating to repeating
• Increase or decrease Repeat Maximum value

Events

• Changing Label, Short Label, Description, External ID, Display Override Label, and help text
• Deletion
• Changing from dynamic to non-dynamic and non-dynamic to dynamic
• Changing Event Window

Forms

• Changing Label, Short Label, Description, External ID, Display Override Label, Mandatory, and help text
• Deletion
• Changing from repeating to non-repeating and non-repeating to repeating
• Increasing or decreasing the Repeat Maximum number
• Changing from non-dynamic to dynamic only

Item Groups

• Changing Label, Short Label, Description, External ID, Display Override Label, and help text
• Deletion
• Changing from repeating to non-repeating and non-repeating to repeating
• Increasing or decreasing the Repeat Maximum number
• Changing Item Group defaults

Items

• Changing Label, Short Label, Description, External ID, Display Override Label, and help text
• Deletion
• Allow unknown (date): No selection to No selection, No selection to Day, No selection to Month & Day, Day to Day, Day to Month & Day, Month & Day to Month & Day
• Allow unknown (date time): No selection to No selection, No selection to Time, No selection to Day and Time, No selection to Month, Day and Time, Time to Time, Time to Day and Time, Time to Month, Day and Time, Day and Time to Day and Time, Day and Time to Month, Day and Time
• Increasing number data type Precision and Length
• Increasing unit Precision and Length
• Increasing Text length
• All Edit checks required

When an amendment fails due to destructive changes, your organization has two options:

• Contact Veeva Support about the failure and initiate the process to allow the destructive change with the amendment.
• Create a new casebook version and restore the removed component. This way, the Casebook Definition version no longer contains a destructive change, and an amendment onto that verison would succeed.

Form Status Post-Amendment

If you chose the Leave as Submitted for Status for Changed Forms option in step 8 above, submitted Forms remain in the Submitted status.

If you chose Set to In Progress, submitted Forms are set to In Progress except for the following amendment changes:

• Adding a Unit Item to a Unit
• Adding a Codelist Item to a Unit