Managing Study Environments

You can create and manage study environments from the Deployments listing page in EDC Tools.

Prerequisites

Configuration

Before you can create Study Environments, a study designer must create a Study Master in Studio.

Required Permissions

Users with the CDMS Deployment Administrator study role can perform the actions described above by default. If your vault uses custom Study Roles, your role must grant you the following permissions:

Type Permission Label Controls
Standard Tab EDC Tools Tab

Ability to access the EDC Tools tab
Functional Permission Manage Deployments

Ability to create and manage study Environments and deploy Studies from EDC Tools, manage and deploy vault-level configuration from Tools > System Tools, and manage and deploy listings, checks, and views in CDB

If your Study contains restricted data, you must have the Restricted Data Access permission to view it.

Learn more about Study Roles.

About Study Environments

Study environments represent your Study as it exists in different stages of development. There are seven (7) types of environments: Development, Migration (when enabled), Validation, Test, Training, Production, and Post Production Test. You’ll build your study in your development environment, test it in one or more test environments, train staff on it in your training environment, and ultimately execute your study from your production environment.

Your environments may be spread across multiple vaults. Your development environment in one, primary vault. Your test and training environments may be housed in that same vault or on a separate vault. Your production environment is most likely to be on a separate vault from your development environment.

Study environments are tracked using the Study Instance object.

Migration Environments: Contact Veeva Support to enable migration environments in your vault.

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

Viewing Study Environments

Once you open your Study Master in Tools > EDC Tools, Vault shows a listing of all Environments for that Study Master. From here, you can initiate deployments and create additional environments.

Latest Casebook Version vs. Build Number

The Latest Casebook Version column displays the latest Casebook Definition version that exists in that environment. The Study Build Number represents both version changes and changes to versionless objects that you move between environments. For example, if you add a new Review Plan to your study design, Vault does not require you to create a new version. However, Vault will increment the build number by one (1).

Use Latest Casebook Version to identify which version of the Study exists, but use Study Build Number to track unversioned changes across environments.

How to Create Study Environments

You can create new Study Environments for your study as needed from EDC Tools. Note that there are limits on how many Study Environments you can have of each type.

To create a new Study Instance:

  1. Navigate to Tools > EDC Tools.
  2. Click your Study Master’s Name in the Study Listing.
  3. From the Actions menu, choose an action to create an environment:
    • + Development: Create a new development-type environment.
    • + Migration: Create a new migration-type environment.
    • + Test: Create a new test-type environment (formerly known as “UAT”).
    • + Validation: Create a new validation-type environment.
    • + Training: Create a new training-type environment.
    • + Production: Create a new production-type environment. (Note that this action is only available if your study doesn’t have a production environment).
    • + Post Production Test: Create a new PPT environment. (Note that this action is only available if the “Enable Copy Study Data” feature is enabled. Learn more.)
  4. In the Create Environment dialog, select a Vault to create your Study Environment in.
  5. Click Continue.
  6. In the Create Environment confirmation dialog, click Create.

Vault creates a new Study Environment. You can now use this environment for development, test, or training.

Test Environments: You can create Test environments, previously known as UAT (user acceptance testing) environments, in any Studies created after the 22R2 release. UAT environments in Studies created before the 22R2 release are still labeled as UAT.

Post Production Test Environment

If you have already deployed to your Production environment and would like to make changes post go live, you can create a Post Production Test environment (PPT) in EDC Tools to test or preview post-production changes before the changes are applied to Production casebooks.

To utilize the Post Production Test environment:

  1. Create a Post Production Test environment, following the steps above.
  2. Hover over your Development or UAT environment to show the Actions menu ().

  3. From the Actions menu, select Deploy.

  4. In the Deploy Study Design dialog, select your PPT environment as the Destination Environment.

  5. Click Deploy.
  6. When deployment is finished, refresh the page.
  7. Hover over your PPT environment to show the Actions menu.

  8. From the Actions menu, select Copy Study Data from Production. Copy Study Data from Production

  9. Click Continue.
  10. Verify your login credentials.
  11. Click Continue. This opens the Copy Study Data from Production page.
  12. Filter results by Site Number then select the Subjects you want to copy study data from.
  13. Click Copy Study Data. Vault begins a job to copy data. Copy Study Data page

Site Number Filter: Note that changing the Site Number filter while choosing subjects will reset the contents of the grid and deselect any subjects that were chosen in the previous filter state.

You can track the progress of your copy on the Deployment History page.

When the copy is finished, Vault sends you an email notification. Once the copy is complete, the data in your PPT environment is available for testing post-production changes.

Available Environment Actions

Hover over an environment in the list to show the Actions menu. You can perform environment-level actions using this menu.

The following actions are available in the environment-level Actions menu:

Environment Actions menu

  • Deploy: Use this action to deploy the latest casebook version in this environment to another environment. Learn more.
  • Restore: Use this action to restore an environment from another.
  • Delete study data: Use this action to delete study execution data in this environment. Note that this option is not available for production environments. Learn more.
  • Rename: Use this action to rename a study environment.
  • Delete: Use this action to delete a study environment.
  • Lock: Use this action to lock a study environment. Learn more.

How to Restore an Environment from Another Environment

To restore from production:

  1. Navigate to EDC Tools > Deployments for your study.
  2. Locate the environment you want to restore in the list of Environments.
  3. Hover over the environment to display the Actions menu.

  4. From the Actions menu, select Restore. Vault opens the Restore Study Design dialog. Restore action

  5. Select a Source Environment to restore from. Restore Study Design dialog

  6. Optional: Enter a Reason for Change.
  7. Click Restore. Vault begins a job to restore your environment from your chosen source environment. When finished, Vault sends you an email notification.

How to Restore a Study Design from a File

You can restore a deleted study design from the backup file that’s automatically created by Vault when an environment is deleted. You can find your backup file(s) in System Tools > Deployment. Note that you can only restore the study design, not study data.

To restore a study design:

  1. Navigate to Tools > EDC Tools.
  2. Click to open the Study Master containing the environment you want to restore.
  3. Create an Environment of the appropriate type, following the steps above.
  4. Hover over the new Environment to show the Actions menu ().
  5. From the Actions menu, select Restore.

  6. In the Restore Study Design dialog, select Restore from File to restore from a backup file. Restore Study Design from File

  7. If you selected Restore from File, select a File.
  8. Click Restore.

How to Rename an Environment

To rename an environment:

  1. Navigate to Tools > EDC Tools.
  2. Click to open the Study Master containing the environment you want to rename.
  3. Locate the Environment in the list.
  4. Hover over the Environment to display the Actions menu.
  5. From the Actions menu, select Rename.
  6. Enter a new Name.
  7. Click Continue.
  8. In the Rename Environment confirmation dialog, click Rename.

Vault renames your Environment. This changes the Label of the environment’s Study Instance record, but not the API Name.

How to Delete an Environment

To delete an environment:

  1. Navigate to Tools > EDC Tools.
  2. Click to open the Study Master containing the environment you want to delete.
  3. Locate the Environment in the list.
  4. Hover over the Environment to display the Actions menu ().

  5. From the Actions menu, select Delete Environment.

  6. In the Delete Environment dialog, enter the environment name to confirm.
  7. Click Delete. Vault begins a job to delete your Environment. When the job finishes, Vault sends you an email notification.

Vault automatically saves the study design’s backup file upon deletion. You can access the backup file from the deployment history and use it to restore the study design if needed.

Environment Type Limits

The following limits apply for study instances:

Type Limit
Development 2
Migration 3
Validation 2
Test 5
Training 2
Production 1
PPT 2

Deployment History

You can use the Deployment History to view a listing of all deployment events related to your Study.

Deployment History action