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, and that version has been deployed to your current environment, you can deploy it to sites using a retrospective casebook amendment. Note that Vault does not apply amendments to locked Casebooks or Forms.

In Data Model V1 Studies, frozen forms may become unfrozen if an amendment updates the form. If the amendment encounters a locked form, it skips the subject.

To apply this behavior to Data Model V2 Studies, contact Veeva Support. Otherwise, you must manually unfreeze.

Vault automatically uses the first Event Group and Event in the study’s schedule to apply the new version.

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. Status for Changed forms: To keep any existing, submitted forms in the Submitted status, select Leave as Submitted for Status for Changed Forms. To set the status of any modified forms as In Progress Post Submit, select Set to In Progress.
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.

Retrospective Amendment Job Log and Output File

Vault provides a CSV job log for retrospective amendment jobs. The output file and log for a successful retrospective amendment job include an output file in CSV format and a log file in TXT format. This log includes details about which objects were affected by the job and whether or not the job was successful on each object.

When your retrospective amendment job is completed, you can download your output files from EDC Tools > Job History. To access these files, click the icon () in either the Log or File column.

The CSV output file you can export for the retrospective amendment job contains the following columns:

• Casebook ID: The ID of the amended Casebook object
• Target Casebook Version: The target version number of the new Casebook Version
• Result: Whether an error occurred for the given Casebook object
• Message: The error message code if an error occurred

Destructive Changes

Vault doesn’t allow you to run retrospective amendment jobs that contain destructive changes. If you need to run a retrospective amendment job that contains a destructive change, contact Veeva Support for help.

If you try to run an amendment containing a destructive change, it will fail.

Destructive changes include the following actions:

• Removing (deleting) an Event Group from a Casebook Definition
• Removing (deleting) an Event from an Event Group
• Removing (deleting) a Form from an Event
• Removing (deleting) an Item Group from a Form
• Removing (deleting) an Item from an Item Group
• Moving any child study object from its parent study object, such as moving an Event from its original Event Group to a different Event Group, as this requires the deletion and recreation of the child object

In Studio, Vault displays a warning when you remove any of these definition relationships. You can identify destructive changes by comparing the latest Casebook Definition version to the previous Casebook Definition version. After downloading the output file, review the Schedule tab. Any change where the Type column is “Object”, the Difference column is “Modified”, and the Latest Version is “[Not Present]” is a destructive change.

When you attempt to run an amendment that contains a destructive change, Vault first determines if there is a destructive change. Then Vault determines 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.

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.

Changes Allowed Between Versions for Retrospective Amendment

The table below reviews the changes allowed between versions for retrospective amendments:

Object	Change	Supported?	Notes
Event Group	Name	No
Event Group	Properties: Label, Description, External ID, Display Override Label, and Help Text	Yes
Event Group	Delete the Event Group	Yes
Event Group	Repeating to Non-Repeating	No	You can only change from Non-Repeating to Repeating, not vice versa.
Event Group	Non-Repeating to Repeating	Yes
Event Group	Increasing or Decreasing the Repeat Maximum Value	Yes	A decrease of the Repeat Maximum for an Event Group only applies to new instances of the Event Group.
Event Group	Changing the Event Group Type to EDC from Unscheduled and vice versa	No
Event	Name	No
Event	Properties: Label, Description, External ID, Display Override Label, and Help Text	Yes
Event	Delete the Event	Yes
Event	Change the Event Type	No
Event	Change from Dynamic to Non-Dynamic and vice versa	Yes
Event	Changes to the Event Window Configuration	Yes
Form	Name	No
Form	Properties: Label, Description, External ID, Display Override Label, and Help Text	Yes
Form	Delete the Form	Yes
Form	Repeating to Non-Repeating	No	You can only change from Non-Repeating to Repeating, not vice versa.
Form	Non-Repeating to Repeating	Yes
Form	Increasing or Decreasing the Repeat Maximum Value	Yes
Form	Change from Dynamic to Non-Dynamic	No	You can only change from Non-Dynamic to Dynamic, not vice versa.
Form	Change from Non-Dynamic to Dynamic	Yes
Form	Change from Restricted to Unrestricted or vice versa	No
Form	Add an Item Group to the Form	Yes
Item Group	Name	No
Item Group	Properties: Label, Description, External ID, Display Override Label, and Help Text	Yes
Item Group	Delete the Item Group	Yes
Item Group	Repeating to Non-Repeating	No	You can only change from Non-Repeating to Repeating, not vice versa.
Item Group	Non-Repeating to Repeating	Yes
Item Group	Increasing or Decreasing the Repeat Maximum Value	Yes
Item Group	Change an Item Group’s Default Data	Yes	Item group default data can change from version to version, but these changes won’t show on the form until the form is reset.
Item	Name	No
Item	Properties: Label, Description, External ID, Display Override Label, and Help Text	Yes
Item	Delete the Item	Yes
Item	Change the Item’s Data Type	No
Item	The following changes to Allow Unknown (Date): No selection to No selection, No selection to Day, No selection to Month & Day, Day to Day, Day to Month & Day, or Month & Day to Month & Day	Yes
Item	The following changes to Allow Unknown (Date): Day to No Selection, Month & Day to Day, or Month & Day to No Selection	No
Item	The following changes to Allow Unknown (DateTime): 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	Yes
Item	The following changes to Allow Unknown (DateTime): Time to No Selection, Day and Time to Time, Day and Time to No Selection, Month, Day, and Time to No Selection, Month, Day, and Time to Time, Month, Day, and TIme to Day and Time	No
Item	Increase to Precision and Length for number, unit, and text (length only) type Items	Yes
Item	Decrease to Precision and Length for number, unit, and text (length only) type Items	No
Item	Remove an Item’s Codelist	No
Item	Changes to Edit Check Properties	Yes

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
• Increasing unit Precision and Length
• Changing Label text