Step 5: Iterate on your Design & Finalize

Studio

Roles


During the course of your user acceptance testing and training, you may find changes that are required before you can publish your study to production.

Create a New Casebook Version in Development

Return to your development environment to make changes to your design.

Create a New Version

When you first begin designing your study, Vault automatically creates a Casebook Definition record for your first version. After you have published this initial version, you’ll need to create new versions before making additional changes to your study design.

To create a new casebook version:

  1. In Studio, navigate to the Study you want to version.
  2. From the Actions menu, select Create New Version.
  3. Optional: Enter a Name for the version. This displays in the Studio Actions menu and in Tools > EDC Tools > Casebook Versions. If you do not enter a Name, Vault names your version with the Version Number.
  4. Select a Change Reason.
  5. Vault creates a new casebook version. This new version displays in Studio. Changes to this version will not affect existing subject casebooks.

You can see the current version number below the breadcrumb menu in Browse view.

Make Design Changes

Use EDC Studio to make your design changes. See the following steps in Stage 1: Study Design for details, as well as Designing a Study in Studio.

  • Step 2: Create Design Definitions
  • Step 3: Create Study Schedule

Validate, Publish & Export

Once you finish your design changes, you must validate, publish, and export it once more before you can run UAT and training against it.

  • Stage 1, Step 8: Validate & Publish the Casebook Version
  • Stage 1, Step 12: Prepare for Staging to UAT

Stage New Version to UAT & Training

Follow the instructions in Step 1: Stage to UAT or Training Vault to import, validate, and publish the new version of your Study in your UAT or training vault.

Then, follow the instructions in Step 3: Deploy to Testing & Training Sites to assign your new version to Sites,

Perform testing and training against each new version as needed.

Prepare Final Design for Deployment

To export a Casebook Definition:

  1. In Studio, navigate to the Study for which you want to export the Casebook Definition.
  2. From the Actions menu, click to expand Casebook Versions and choose which version to export.
  3. From the Actions menu, select Export.
  4. Select the checkboxes of the components you want to include in the export.
  5. Optional: Enter a file name. By default, Vault names the file with the Study Name and export date.
  6. Optional: Select the Publish Version checkbox to publish your Casebook Definition upon export.
  7. Click Export. When the export is complete, Vault EDC will send you an email, including a link to download the ODM XML and a summary CSV file indicating any Item Definitions that Vault skipped exporting due to errors.

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Roles