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, you can choose to generate it in CSV or SAS (sas7bdat) format. CDB then generates a set of files, one for each export listing. Once you generate the export package, you or any other CDB user with access to your Study can download the export package (a ZIP file containing the collection of listing files, either CSV or sas7bdat, and the manifest file, “manifest.json”, describing the package contents) to share with study stakeholders, such as regulatory authorities, medical monitors, and statisticians.

Availability: 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.


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, dashboards, and CDBs)

Functional Permission View Export

Ability to access the Export page

Functional Permission Create Export Definition

Ability to create and copy Export Definitions

Functional Permission Generate Export Package

Ability to generate a CSV or SAS export package

Functional Permission Delete Export Definition

Ability to delete an Export Definition

Functional Permission View Export Packages

Ability to access Export > Packages to view generated export packages

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 Exports

The Export page has two tabs, Definitions and Packages. From Export > Definitions, you can view, create, and edit Export Definitions for your Study. From Export > Packages, you can view all generated export packages and review an error log for any failures.

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. Workbench shows a clock icon () in this column if this definition has scheduled exports set up. Hover over the icon to show the schedule.
Status An Export Definition can be in one of two statuses: Draft and Published.
Listings The number of data listings within the Export Definition
Type The type of Export Definition. See Export Types below for details.
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).

Packages

Workbench lists all packages generated for a Study in Export > Packages. The table below lists the details of each column for the package listing:

Column Description
Name This column lists the Title of the Export Definition used to generate the package, the Date and Time the package was generated, and the number of listings included in the package.
Type This column lists the Type of the Export Definition used to generate the package.
Processed By The Name of the user who initiated package generation and the Date and Time they did so.
Status This column lists the status of the package: In Progress, Complete, or Error. When Complete, click Download () to download the package.

Sort Packages

You can sort this listing by Name, Processed By, Process Date, and Process Status. 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, Process Date).

Errors

If package generation fails, you can view a list of errors from Export > Packages.

To view errors:

  1. Navigate to Export > Packages for your Study.
  2. Locate the failed package in the list.
  3. Click View Issue Log (). View Issue Log

  4. Workbench opens the Issues panel. This lists each error that occurred during package generation.
  5. Optional: Click Download () to download the issue log.
  6. Click Close () to close the Issues panel.

Export Types

Workbench supports three types of exports: None, Raw, and SDTM. The default is None, which allows you to create your own export definition without the defined conventions that the Raw and SDTM types include.

Raw

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

  • The package contains an export listing for each core listing within the study, even if the form has no data.
  • Any date and datetime items display both the default and the RawDate() format. See the table below for examples of RawDate() format dates.
  • Items with units include columns for the translated name and unit value. See the table below for examples of unit columns.
  • The package contains additional System Listings for contextual header information. See a detailed list below.

Export Listings for Forms

Each form’s listing in your raw export will include the following columns, in addition to columns for each Item on the Form:

  • Study.Name
  • Site.Number
  • Subject.Name
  • EventGroup.Name
  • EventGroup.SeqNbr
  • Event.Name
  • Event.Date
  • Event.Status
  • Form.Name
  • Form.DataSource
  • Form.SeqNbr
  • Form.LastModifiedDate
  • ItemGroup.SeqNbr

System Listings

Raw exports include the following System Listings, which list operational metadata for your study. The table below lists the columns included in each System Listing.

System Listing Columns
Sys_Sites
  • Study.Name
  • Site.Country
  • Site.Number
  • Site.Nme
  • Site.PI
Sys_Subjects
  • Study.Name
  • Site.Country
  • Site.Number
  • Subject.Name
  • Subject.Status
Sys_Events
  • Study.Name
  • Site.Number
  • Subject.Name
  • EventGroup.Name
  • EventGroup.SeqNbr
  • Event.Name
  • Event.Date
  • Event.Status
Sys_Forms
  • Study.Name
  • Site.Number
  • Subject.Name
  • EventGroup.Name
  • EventGroup.SeqNbr
  • Event.Name
  • Form.Name
  • Form.SeqNbr
  • Form.Status
  • Form.CreatedDate
  • Form.SubmissionDate
  • Form.SubmissionCount
  • Form.SDVDate
  • Form.DMRDate
  • Form.FrozenDate
  • Form.LockedDate
  • Form.Signed
Sys_ILB
  • Study.Name
  • Site.Number
  • Subject.Name
  • EventGroup.Name
  • EventGroup.SeqNbr
  • Event.Name
  • Form.Name
  • Form.SeqNbr
  • ItemGroup.Name
  • ItemGroup.SeqNbr
  • Item.Name
  • Item.ILBReason

Raw Date Formats

For date and datetime items, Workbench includes the default date format and the RawDate() format for the date. In RawDate() format, partial dates and times display without any modifications.

Date or DateTime as Recorded Raw Format
1 27-Oct-2020 27-Oct-2020
2 ?-Oct-2020 UN-Oct-2020
3 ?-?-2020 UN-UNK-2020
4 27-Oct-2020 10:40 27-Oct-2020 10:40
5 27-Oct-2020 ? 27-Oct-2020 UN:UN
6 ?-Oct-2020 ? UN-Oct-2020 UN:UN
7 ?-?-2020 ? UN-UNK-2020 UN:UN

Items with Unit Columns

For unit-type Items, Workbench includes additional columns for the translated name and unit value. The table below shows the included columns for the “Weight” item, which is collected in kilograms.

Weight Weight_UOM Weight_TRANSLATED Weight_UOM_TRANSLATED
65 kgs 143.3 lbs

SDTM

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. Select Raw or SDTM for Type to create an export definition of that 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.

Export Definition Workflow

All Export Definitions start in the Draft status. Each listing within the definition also starts in Draft. Once all listings are marked as Ready, the Export Definition moves into the Published status. If at any time a listing is invalidated, the Export Definition moves into the Draft status. To return to Published, the invalid listing must be removed or updated. If any listings return to Draft, the Export Definition also returns to the Draft status.

You can generate an export package for an Export Definition that is in the Draft or Published statuses.

Look to the Status Badge to identify the status of an Export Listing or Export Definition. The Status Badge is displayed in the definition list, the list of listings within the definition, and on the listing page.

Draft status badge

How to Mark a Listing as Ready

To mark an Export Listing as Ready:

  1. Open the Export Listing in Workbench > Export > Definitions.
  2. Verify that your listing is ready for use.
  3. Click Ready in the Status Toggle. Ready status toggle

You can return the listing to the Draft status by clicking Draft in the Status Toggle.

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 properties as needed. 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 as a set of CSV or SAS files.

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

  4. Select CSV or SAS for the export format.
  5. Once Workbench generates the package, click Download () to download the export package (ZIP). Download export package

Schedule Recurring Exports

You can schedule a daily, weekly, or monthly export and select users to notify of the export package’s availability. Once a scheduled export finishes generating the package, you can download it from Export > Definitions, or deliver it via FTP to a location of your choosing.

To schedule a recurring export:

  1. Navigate to Export > Definitions.
  2. Click to open an Export Definition.
  3. From the Export Definition () menu, select Properties.
  4. Click Edit.
  5. Select the Schedule checkbox.
  6. Select a Date and Time. This is the date of the first export. Workbench will then generate future export packages after the chosen interval (step 7) has passed. For example, if you select “Weekly” and “7 December 2020, 12:00 AM”, Workbench will generate an export package at that time, and then the next export would occur on “14 December 2020, 12:00AM” .
  7. Select Daily, Weekly, or Monthly as an Interval.
  8. Select CSV or SAS for Format. This determines the type of files that Workbench generates for the export package.
  9. Optional: Select the Delivery checkbox and select an FTP delivery location. See Create an FTP Destination for details about creating destinations for delivery.
  10. Click Save.

How to Edit a Scheduled Export

To edit a scheduled export:

  1. Navigate to Export > Definitions.
  2. Click to open an Export Definition.
  3. From the Export Definition () menu, select Properties.
  4. Click Edit.
  5. Make changes as needed to the export Schedule and Delivery.
  6. Click Save.

How to Stop a Scheduled Export

At any time, you can stop a scheduled export. The export won’t reoccur until you start it again.

To stop a scheduled export:

  1. Navigate to Export > Definitions.
  2. Click to open an Export Definition.
  3. From the Export Definition () menu, select Properties.
  4. Click Edit.
  5. Clear the Schedule checkbox.
  6. Click Save.

Create an FTP Destination

Workbench supports the use of both the provided Veeva Vault FTP server and third party FTP servers.

A user with the Vault Owner security profile can set up the Destination for a scheduled export from Tools > EDC Tools > FTPs. If you plan to use a location other than the provided Vault FTP server, you must already have that server set up.

To set up the Destination for your Vault FTP server:

  1. Navigate to your Study in Tools > EDC Tools > FTPs.
  2. Click + Add FTP.
  3. Enter a Name. This will display in the Destination drop-down menu in Workbench.
  4. Select Veeva Vault for Type. Even if you’re using a third party FTP server, use Veeva Vault as the type.
  5. Enter your User Name. This is the user name that you use to log in to Vault, including the domain, with the host in front. For example, “verteopharma.veevavault.com+cordelia.hunter@verteopharma.com”.
  6. Enter your Password.
  7. Enter the Host. This is the URL of your vault: {DNS}.veevavault.com. For example, “veepharm” is the DNS in veepharm.veevavault.com.
  8. Click Save.
  9. Navigate to Admin > Business Admin.
  10. Select Study Settings for Component.
  11. Locate the Study Settings records for your FTP connection. Vault names these with “connection.{field}”.
  12. Click to open connection.destinationDir.
  13. Clear the Value field.
  14. For Value, enter the directory path where you want to deliver the package.
  15. Click Save.

If your FTP server is using FTPS:

  1. Navigate to Admin > Business Admin.
  2. Select Study Settings for Component.
  3. Locate the Study Settings records for your FTP connection. Vault names these with “connection.{field}”.
  4. Copy the value in the Grouping Key column.
  5. Click + Create.
  6. For Name, enter “ftp_scheme__v”.
  7. For Grouping Key, paste the Grouping Key value you copied in step 4.
  8. Select your Study.
  9. For Value, enter “ftps”.
  10. Click Save.