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 and dashboards)

Functional Permission View Export

Ability to access the Export page

Functional Permission Create Export Definition
Functional Permission Generate Export Package
Functional Permission Delete Export Definition
Functional Permission View 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 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.
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).

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.

System Listings

Raw exports include the following System Listings, which list operational metadata for your study:

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 2020-10-27
2 ?-Oct-2020 2020-10-UN
3 ?-?-2020 2020-UN-UN
4 27-Oct-2020 10:40 2020-10-27T17:40:00.000Z
5 27-Oct-2020 ? 2020-10-27TUN:UN:UN.UNKZ
6 ?-Oct-2020 ? 2020-10-UNTUN:UN:UN.UNKZ
7 ?-?-2020 ? 2020-UN-UNTUN:UN:UN.UNKZ

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 of the 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 Invalid 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 a Format.
  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

A user with the Vault Owner security profile can set up the Destination for a scheduled export from the Vault Admin area. 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:

  1. Navigate to Admin > Business Admin.
  2. Select Study Settings for Component. Component Selector

  3. Click + Create.
  4. Enter a Name. See the table below for the required Name for each Study Setting record.
  5. Enter a Grouping Key. You must use the exact same value for each Study Setting record for the FTP destination. This is the label that displays in the Destination drop-down in Workbench.
  6. Select your Study.
  7. Enter a Value. See the table below for the required Value for each Study Setting record.
  8. Click Save + Create.
  9. Repeat steps 4 through 8 for each required Study Setting record.
Required Name and Value for Study Settings
Name Value
ftp_host__v {DNS}.veevavault.com. For example: “veepharm” is the DNS in veepharm.veevavault.com.
ftp_dir__v The directory path of the location you want to deliver the export to. When using the Vault FTP server, use “/workbench/_delivery”
ftp_port__v This does not typically need to be added and will default to Port 21.
ftp_scheme__v The protocol to use when connecting with the destination. Enter “ftp” or “ftps”.
ftp_username__v The Username of the user you’re delivering the export package to. For the Vault FTP server, use “{DNS}.veevavault.com+{USERNAME}”. This uses the same user name that you log in with. For example: veepharm.veevavault.com+tchung@veepharm.com.
ftp_password__v The Password of the user you’re delivering the export package to. For the Vault FTP server, use your login password for this vault. This is the same password used for your standard login.