Importing Vault EDC Data

With Vault CDMS, you can easily move data from Vault EDC into Veeva CDB with the Workbench Export job. The Workbench Export job exports your study’s execution data from EDC to the CDB Workbench application. In CDB Workbench, CDB creates a Core Listing for each Form in your study. Each time you run this job, CDB updates the data within to reflect that in EDC.

If your vault was created after the 24R2 release, you have incremental import enabled in your vault. Skip to the Incremental Import section below. If your vault was created prior to the 24R2 release, you may not have this feature enabled yet.

Run the Workbench Export Job in EDC

You can choose to run the Workbench Export job once, or schedule it on a recurring basis.

This job sends a package of all study data for Forms in the Submitted and In Edit statuses.

To create a Workbench Export job:

1. Navigate to Tools > EDC Tools > Jobs.

2. Click + New Job.

3. For Type, select Workbench Export.
4. To run the Workbench Export job once, click Run. To schedule a recurring export job, proceed to step 5.
5. Select a Frequency other than Run Now.
6. Enter a descriptive Name for your job. This displays in the Job Name column within the Job Schedule tab.

7. Select a time to Run at.

8. Click Save.

Job Statuses

Vault displays the status of your job in the job history, along with other details about the job. You can click the Information () icon for additional details about a job.

Job Logs & Output Files

Vault provides a CSV job log file for each job. This log includes details about which objects were affected by the job and whether or not the job was successful on each object. When applicable, Vault also provides a link to the output files from a job. For example, a link to download the ODM XML file for an ODM Export job.

To access these files, click the icon () in either the Log or File column.

You can view tables with potential audit descriptions for each study object below:

Casebook

Event

Event Group

Form

Item

Item Group

Link Form

Protocol Deviation

Subject

Vault automatically sends the output file to CDB Workbench. You can download and view the output from EDC Tools > Jobs or from Workbench > Import.

Importing the Data in Workbench

Workbench automatically imports the data exported from Vault EDC, without any additional action from you. Similarly to how 3rd party data is imported into Workbench, the data exported from Vault EDC is normalized at the Form level.

For the import to finish, a user within your study must open a listing. This moves the import into the Complete status. If no one opens a listing, the import remains in the In Progress status.

When import is finished, Workbench sends you, as well as any other users subscribed to the Source, an email notification. If the reprocessing of a package results in a change from the previous load, Workbench will also send a notification to you and users subscribed to that Source.

Workbench automatically generates a Core Listing for each unique Form in a Study. The default CQL query for these listings is:

SELECT @HDR, * from source.filename

For example, if a Study contains a Chemistry form and a Hematology form, CDB creates two Core Listings: Chemistry and Hematology, using these queries:

SELECT @HDR, * from labs.Chemistry

SELECT @HDR, * from labs.Hematology

Viewing Import Status

You can check the status of your import package from Import > Packages. This page lists the status of every import package, from both Vault EDC and 3rd party tools. You can also download import packages and issue logs (errors and warnings) from this page.

Users without the Restricted Data Access permission can download the import package log, but they can’t download the data file. Users with restricted data access can download a package with blinded data.

Any time you import a package into Workbench, Workbench automatically reprocesses the most recent packages for all other sources. For example, when your nightly Workbench Export EDC job runs, and then imports into Workbench, Workbench reprocesses your most recent Lab Data and Imaging packages as well. For earlier packages from the same Source, Workbench marks them as Replaced by the newer package.

You can easily filter the list to show only complete or failed imports using the Import Status Filters. Click Error to show only failed imports, or click Complete to show completed imports.

Workbench Import Statuses

When an import package is able to import with only warnings, Workbench highlights the status in orange to indicate that there are warnings. When import finishes, you can download the issue log to review the warnings.

Download the Import Package

To download the import package:

1. Navigate to Import > Packages.
2. Locate your import package in the list.

3. Click the Package link.

4. Extract the files from the ZIP folder and view them in a tool of your choosing.

Download the Logs

You can download the Import Log (CSV) for any import and the Issue Log (CSV) for an import that fails. The Import Log lists details about the import job and the data ingestion into Workbench.

The import log lists the following:

• Transformation Start Time
• Transformation Completion Time
• Transformation Duration
• Import Start Time
• Import Completion Time
• Import Duration

To download the import log:

1. Navigate to Import > Packages.
2. Locate your import package in the list.
3. From the Package () menu, select View Package Details.
4. In the Package Details panel, click Issues.
5. Optioanl: In the Issues tab, click Download () to download a CSV of the issue log.

Issue Log

The Issue Log lists all errors and warnings that Workbench encountered while importing the package.See a list of possible errors and warnings here.

To view the issue log:

1. Navigate to Import > Packages.
2. Locate your import package in the list.
3. From the Package () menu, select View Package Details.
4. In the Package Details panel, click Issues.
5. Optional: In the Issue Log panel, click Download () to download a CSV of the log.

To download the issue log without first viewing it in the application:

1. Navigate to Import > Packages.
2. Locate your import package in the list.
3. From the Package () menu, select Download Issue Log.

Restricted (Blinded) Forms

In Vault EDC, study designers can mark Forms as Restricted. This means that all Items on the Form are also Restricted.

For users who have access to restricted data (typically lead data managers), restricted data behaves the same way as unrestricted data. For blinded users (users without the Restricted Data Access permission), the following behavioral rules apply to any imported restricted data:

• If an Item (column) is restricted:
  • The CQL projection doesn’t return the restricted item’s column.
  • The CQL projection doesn’t return any derived columns that reference the restricted item.
  • If a blinded user references the restricted Item in their CQL statement, CQL still doesn’t return the column.
  • SHOW and DESCRIBE do not return the restricted Item.
• If a row is restricted:
  • The result set doesn’t return any rows from the Form or Item Group.
• If a listing file (csv) is restricted:
  • The default @HDR columns are included in the listing, but no Item columns are included.
• If a Source (package) is restricted:
  • CQL doesn’t return any Items or column results from the restricted Source in any listing.
  • CDB marks all Item Definitions, Item Group Definitions, and Form Definitions within the Source as restricted.
  • All data rows are marked as restricted.
  • The default @HDR columns will still appear in the core listings.

Incremental Import (24R2 & Later)

With incremental import, CDB imports your study data from Vault EDC every fifteen (15) minutes for new data. This happens automatically, without any action required from the user. Data from Vault EDC is normalized at the form level.

Study design changes are loaded once a day at 12:00 GMT. If a design change is detected, all incremental refreshes are paused until 12:00 GMT when the latest study design is loaded.

These incremental import packages include the following data:

• Study properties
• Site properties
• Subject properties
• All casebook data
• Queries
• SDV Status
• DMR Status

CDB creates a Core Listing for each Form in your Study. A Core Listing contains the following columns, but note that an administrator may have configured your Study to have different core listing columns:

• Study.Name
• Site.Name
• Site.PI
• Event.Name
• Event.Date
• Event.Status
• Subject.Name
• Subject.Status
• A column for each Item on the Form

When import is finished, CDB sends a notification to any users subscribed to the Source, an email notification.