Exporting Data


You can group data listings together for export as Export Definitions from the Export area of Data Workbench. For each Export Definition, you can add one or more of the data listings from your study. When you generate the export package, Workbench creates a CSV file for each data listing. Once you generate the export package, you or any other Workbench user with access to your Study can download the export package (a ZIP file containing the collection of listing CSVs) to share with study stakeholders, such as regulatory authorities, medical monitors, and statisticians.

In the current release, Vault Clinical DataBase (CDB) is only available to specific early adopter customers. Contact your Veeva Services representative for details.
Prerequisites

You can export data based on the system-generated Core Listings, but if you want to export data from custom listing formats, you must first create those listings.


The following permissions are required to perform the actions described below.

By default, users with the standard CDMS Lead Data Manager and CDMS Data Manager study roles are able to perform the actions described below. If your organization uses custom roles, then your role must grant the following permissions:.

Type Permission Label Controls
Functional Permission Workbench Tab

Ability to access and use the Data Workbench application, via the Workbench tab

Functional Permission View Casebook

Ability to view information about and from subject Casebooks (for reports and dashboards)

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

Learn more about Study Roles.


Accessing Export

You can access your Export Definitions from the Export area of Data Workbench. You can navigate to the Export area from the Navigation Drawer or the Study menu.

Export in the Navigation Drawer Export in the Study Menu

Viewing Export Definitions

Workbench lists all Export Definitions for your study in Export > Definitions. The table below details each column of the Export Definition listing:

Column Description
Name The Title of the export definition, defined during definition creation
Status An Export Definition can be in one of three statuses: Draft, Published, and Invalid. In the current release, all definitions remain in the Draft status.
Listings The number of data listings within the Export Definition
Type In the current release, Export Definitions are not assigned types.
Last Modified The date and time of the last modification to the Export Definition and the name of the user who made the change.
Latest Package The status of the export package and the date and time the package was generated. Click Download to download the package.

You can sort this listing by Latest Package, Modified By, Modified Date, or Name. Select a sort column and order from the Sort By menu.

Sort By menu

Click Reset in the Sort By menu to return to the default sort order (Descending, Modified Date).

SDTM Exports

When creating an Export Definition, you can choose to use SDTM format (by selecting SDTM for Type). SDTM export packages have the following characteristics:

  • Every listing CSV includes a column for Domain (the Short Title of the listing).
  • Listing CSV files are named using the short title (“short_title.csv”).
  • All Date, DateTime, and Time items use ISO8601 format.
  • Unknown dates and times are formatted as shown in the table below.
  • Columns for data items use the SDTM Name or the External ID of the EDC definition, based on the selection during export definition creation.
Date and Time as Originally Recorded Interval of Uncertainty Nominal Date/Time (--DTC)
1 March 15, 2020 13:14:17 Complete date 2020-03-14T13:14:17
2 March 15, 2020 13:14 Unknown seconds 2020-03-15T13:14
3 March 15, 2020 13 Unknown minutes 2020-03-15T13
4 March 15, 2020 Unknown time 2020-03-15
5 March, 2020 Unknown day 2020-03
6 2020 Unknown month 2020

Create an Export Definition

To create an Export Definition:

  1. Navigate to Export > Definitions.
  2. Click + Create …. Create button

  3. Enter a Title for your Export Definition. This displays in the Name column of the Export Definition list.
  4. To create an SDTM export definition, select SDTM for Type. Otherwise, leave this set to None.
  5. If you choose SDTM, you can select Auto generate column labels with EDC External name to use the External ID for column labels. Otherwise, leave this set to Auto generate column labels with EDC SDTM name to use the SDTM Name.
  6. Optional: Enter a Description.
  7. Click Next.
  8. Optional: Click Expand or Collapse to expand and collapse listing categories and export definitions. Workbench groups listings by Category in Available Listings and by Export Definition in Export Definitions.
  9. Drag and drop a Listing or Listing Category from Available Listings to Selected Listings. You can also drag and drop an Export Definition to Selected Listings to automatically add every listing from that definition. Drag and drop listings into the Export Definition

  10. Continue dragging and dropping listings into Selected Listings until the Selected Listings include everything you want in your Export Definition.
  11. To remove a listing from the definition, click Remove (). Removing a listing

  12. When finished, click Next.
  13. Optional: Enter a Short Title for your export listings. Workbench uses the Short Title as the filename for the listing inthe export package and to populate the Domain column in SDTM exports.
  14. Optional: Edit the Title for your export listings.
  15. Click Save.

You can now generate and download the export package for this Export Definition.

Adding a listing to the Export Definition creates a copy of that listing as an Export Listing. Any actions you take on the Export Listing only apply to it, and not the original core or custom listing.

Edit an Export Definition

After creating an Export Definition, you can return later and modify which listings are included, edit the definition’s properties, and rename listings.

Note that you can only save changes to definitions that you created. To make changes to someone else’s listing, you can create a copy of it to make your changes.

How to Rename Listings

You can easily rename export listings in your Export Definition. Renaming a listing here only renames the Export Listing. It doesn’t rename the original data listing.

To rename a listing:

  1. Navigate to Export > Definitions.
  2. Open your Export Definition.
  3. In the Export Listings table, click Edit () to enter Edit mode. Edit button

  4. Enter the new name for your listing in the text field. Listing title text field

  5. Click View () to return to View mode and save your changes. View button

How to Modify Included Listings

You can add and remove listings from an Export Definition.

To modify included listings:

  1. Navigate to Export > Definitions.
  2. Click to open your Export Definition.
  3. From the Actions menu (), select Select Listings. Modify Listings action

  4. Optional: Click Expand or Collapse to expand and collapse listing categories and export definitions. Workbench groups listings by Category in Available Listings and by Export Definition in Export Definitions.
  5. Drag and drop a Listing or Listing Category from Available Listings to Selected Listings. You can also drag and drop an Export Definition to Selected Listings to automatically add every listing from that definition. Drag and drop listings into the Export Definition

  6. Continue dragging and dropping listings into Selected Listings until the Selected Listings include everything you want in your Export Definition.
  7. To remove a listing from the definition, click Remove (). Removing a listing

  8. Click Next.
  9. Optional: Enter a Short Title for your export listings. Workbench uses the Short Title as the filename for the listing in the export package.
  10. Optional: Edit the Title for your export listings.
  11. Click Save.

How to Edit Export Definition Properties

To edit the properties of an Export Definition:

  1. Navigate to Export > Definitions.
  2. Click to open an Export Definition.
  3. From the Export Definition () menu, select Properties. Properties menu item

  4. In the Properties dialog, click Edit . Properties dialog in View mode

  5. Edit the Title and Description. Properties dialog in Edit mode

  6. Click Save.

Copy an Export Definition

You can copy an Export Definition using Save As.

To copy an Export Definition:

  1. Navigate to Export > Definitions.
  2. Click to open your Export Definition.
  3. From the Export Definition () menu, select Save As. Save As action

  4. Optional: Enter a Title for your new export definition. By default, the Title is the title of the original definition with a “2” appended to it.
  5. Optional: Enter a Description.
  6. Click Save.

How to Delete an Export Definition

Note that you can only delete Export Definitions that you created.

To delete an Export Definition:

  1. Navigate to Export > Definitions.
  2. Locate your Export Definition in the list.
  3. From the Export () menu, select Delete.

Generate & Download an Export Package

You can generate and download an export package from any existing Export Definition.

  1. Navigate to Export > Definitions.
  2. Locate an Export Definition in the list.
  3. From the Export () menu, select Generate Package. Generate Package

  4. Once Workbench generates the package, click Download () to download the export package (ZIP). Download export package