Managing Casebook Versions


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

Accessing EDC Tools

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

Access EDC Tools from the Tools Tab

By default, once you open EDC Tools, Vault displays a list of automated deployment Studies. You can use the Automatic and Manual radio buttons to switch between these listings. Select Manual to access your manual deployment Studies.

Select Automatic or Manual

For manual deployment Studies, click on the Study to open EDC Tools for that Study. For automatic deployment Studies, click on the Study to open the Deployments page. From here, you can click on an Environment to open EDC Tools for that study environment.

Once you’ve entered the EDC Tools area, select your Study if you have access to more than one Study. To return to the study list, click Back to Study Listing.

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. There are two types of amendments: retrospective and, if enabled, prospective.

Contact Veeva Support to enable Prospective Amendments in your vault.

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.

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.

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.

All Versions subtab in EDC Tools > 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.

Active Versions by Site subtab in EDC Tools > Casebook Versions

Amendment History

From Amendment History, you can view a list of all past amendments within your study (both retrospective and, if enabled, prospective amendments). 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.

In Amendment History, 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.

Amendment History subtab in EDC Tools > Casebook Versions

Deploying to Sites

Once a clinical programmer 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

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. Selected Sites

  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. Set Active Version button

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

  7. Click Set Active Version. Set Active Version confirmation button

  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 clinical programmer 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 frozen and locked Casebooks or Forms.

Prerequisite:
Before you can initiate an amendment, the version that you want to use must be available in your environment and you must first update the Active Version of any site you’re upgrading.

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. Select a Start Event. This Event is where Vault starts applying changes from the new version to existing casebooks.
  8. 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.
  9. Click Run Now. Vault begins a job to apply your retrospective amendment to your sites. As part of this process, Vault also re-runs all of your study’s Rules. Vault sends you an email notification when the job is complete. You can view the job’s status and log from EDC Tools > Jobs.

    Run Now

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.

How to Initiate a Prospective Amendment

Once a clinical programmer has published a new version of your study, you can deploy it to sites using a prospective casebook amendment. Note that vault does not apply amendments to frozen and locked Casebooks or Forms.

Prerequisite:
Before you can initiate an amendment, the version that you want to use must be available in your environment and you must first update the Active Version of any site you’re upgrading.

To initiate a prospective 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 Prospective Amendment or select New Prospective 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. Click Run Now. Vault begins a job to apply your prospective amendment to your sites. As part of this process, Vault also re-runs all of your study’s Rules. Vault sends you an email notification when the job is complete. You can view the job’s status and log from EDC Tools > Jobs.

    Run Now

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. Any new forms in existing casebooks will also reference that version.

Which permissions control your access depends on when your vault was created. If your vault uses the Role by Study feature, see the first section, Role by Study Permissions. If your vault does not use the CDMS Role by Study feature, see the second section, Profile Permissions.

Role by Study Permissions

Users with the standard CDMS Lead Data Manager application role and a Security Profile that grants access to the EDC Tools can perform the actions described above by default. If your vault uses custom Application Roles, your role must have the following permissions:

Type Permission Label Controls
Functional Permission EDC Tools Tab

Ability to access the EDC Tools tab

Functional Permission Manage Amendments

Ability to initiate subject transfers, retrospective amendments, and prospective casebook amendments, from EDC Tools

Learn more about Study Roles.

Profile Permissions

Users with the Vault Owner and EDC Lead Data Manager security profiles can perform the actions described above. If your vault uses custom security profiles, you must have the following permissions to manage casebook versions:

Type Permission Controls
Security Profile EDC: Access: Study Tools You must have a role for all sites in your study to access the EDC Tools area.

Learn more about permission sets.