Migrating to Versionless Labs

22R1 & Earlier

With the 22R2 (August 2022) release, CDMS introduced the Versionless Labs feature. This feature moved Lab Codelist Definition and Lab Unit Definition objects out of Studio and into the Labs module. Lab Units and Lab Codelists are now managed solely in the Local Labs module (Labs tab). Changes to the Standard Unit, Conversion, and increases to Precision and Length are allowed after deployment to production (post go live).

If your Study was created after the 22R2 release, your Study uses this model automatically. If your Study was created prior to the 22R2 release, you must migrate your Study to the new, global model for versionless labs.

Prerequisites

Your Study must be using Data Model Version 2 (Data Model Version set to “2” on your study’s Study Configuration record). Studies created after the 20R2 (August 2020) release are automatically on Data Model Version 2.

Contact Veeva Support to upgrade to Data Model Version 2.


You must have the Vault Owner security profile to perform the actions described below.


Preparing to Migrate

Before you can begin the migration process, you must create a Global Lab Migration record for your Study, which you will use to manage the migration process. We also recommend that you use the Label Diff Report to ensure that you’ve created all of the necessary Units and Codelists in Labs to match those you have in Studio.

Create a Global Lab Migration Record

To create a Global Lab Migration record for your Study:

  1. Navigate to Admin > Business Admin.
  2. In the Components menu, search for “CDMS Feature Migration”.
  3. Click CDMS Feature Migration.

  4. Click + Create.

  5. For Object Type, select Global Lab Migration.
  6. Click Continue.
  7. Select your Study. This drop-down only includes Studies using Data Model Version 2 that aren’t already migrated. If your vault only contains one eligible Study, Vault automatically selects that Study.
  8. Click Save.

Label Diff Report

You can use the Label Diff Report to review the differences between the units and codelists you have configured for labs in Studio (study-level) and those you have configured globally via the Labs tab.

To generate the Label Diff Report:

  1. Navigate to Admin > Business Admin > CDMS Feature Migration.
  2. Locate your study’s Global Lab Migration record in the list.
  3. Click the record’s Name to open it.
  4. From the All Actions menu (), select Run Label DIff Report.

  5. Vault begins a job to generate the report.When finished, Vault sends an email notification with a link to download the report.

You can also access the report from the Attachments section. Click Download () to download it.

Clicking the hyperlink Filename opens a viewable rendition (PDF) of the Excel™ file.

Validation

As part of the migration process, Vault checks for the following:

  • Name of the Unit Item doesn’t match the Name of the Lab Unit Item
  • Name of the Codelist Item doesn’t match the Name of the Lab Codelist Item
  • Length of the Item for the Unit doesn’t match the Length of the Lab Analyte
  • Precision of the Item for the Unit doesn’t match the Precision of the Lab Analyte
  • Values for Hidden don’t match between Studio and Labs

The Conversion formula for a Unit Item can mismatch between the Unit Item and the Lab Unit Item. Vault will automatically use the Conversion formula for the Lab Unit Item.

Running Migration

Once you are ready to migrate, you can start the job from your study’s Global Lab Migration record.

The migration process has eight (8) phases. Vault moves your Study through these phases automatically.

  • Studio Migration
  • Studio Migration Validation
  • EDC Migration
  • EDC Migration Validation
  • EDC Cleanup
  • EDC Cleanup Validation
  • Studio Cleanup
  • Studio Cleanup Validation

Migration by Environment: We recommend that you first migrate your TEST (UAT) environment. Then, you can deploy the migration change downstream after testing.

To run migration:

  1. Navigate to Admin > Business Admin > CDMS Feature Migration.
  2. Locate your study’s Global Lab Migration record in the list.
  3. Click the record’s Name to open it.
  4. From the All Actions menu (), select Start Migration.

  5. In the Start Migration confirmation dialog, click Continue.

  6. Vault begins the migration process. When finished, Vault sends an email notification.

While in progress, your study’s Global Lab Migration record will stay in the Migration In Progress lifecycle state. You can check the lifecycle state in the header.

As Vault finishes each phase of the migration process, the Phase Information section is updated with the current phase.

Restarting Failed Migration

If your migration fails, you can restart it after resolving any issues.

To restart migration:

  1. Navigate to Admin > Business Admin > CDMS Feature Migration.
  2. Locate your study’s Global Lab Migration record in the list.
  3. Click the record’s Name to open it.
  4. From the All Actions menu (), select Restart Migration.

  5. In the Restart Migration confirmation dialog, click Continue.

  6. Vault restarts the migration. You can track its progress like the original migration. When finished, Vault sends an email notification.

Accessing Migration Job Logs

Log files (TXT) are available for individual phases from the Attachments section. Click Download () in a log’s row to download it. You can click Download All to download all available job logs.

Clicking the hyperlink filename opens a preview of the file.

Vault names each log file with its phase, for example, “studio_migration__v.txt”.

For each attempt at migration, Vault generates a new version of the log file. If you need to access an earlier version, you can do so from the Version History.

To access the Version History:

  1. Locate the log file in the list of attachments.
  2. In that file’s row, select Version History from the Actions menu ().

  3. In the Attachment Version History dialog, you can review the available versions.
  4. Click Download () in a version’s row to download that file.

  5. When finished, click Close.

Study Lock During Migration

While migration is in progress, your study is locked. Vault disables the Analyte Library, System General Settings, Reports Mass Updates, and Study General Settings tabs in Labs. The following EDC actions are also disabled until migration is finished:

  • Studio: Add/Remove Study Objects from the Schedule
  • Studio: Create/Edit/Delete any Study Objects
  • Studio: Copy from Study
  • Studio: Validate
  • Studio: Export
  • Randomization: Invalidate Subjects
  • Add New Event
  • Add Casebook
  • Delete Casebook
  • Enter Data
  • Add New Instance of a Repeating Event Group, Form, or Item Group
  • Add/Edit/Reset New Events
  • Add/Edit/Reset Unscheduled Events
  • Provide eSignature
  • Clear eSignature
  • Open/Answer Close Queries
  • Open/Answer/Close Coding Queries
  • SDV
  • DMR
  • Create/Update Protocol Deviations
  • Export Detail PDF
  • Export Blank PDF
  • Perform Assessments
  • Add/Edit Kit
  • Randomize Now
  • Freeze
  • Lock
  • Mark as Intentionally Left Blank
  • Mark as Did Not Occur
  • Reset
  • Add/Remove Form Links