Enabling Forms for Coding


You can easily identify coding Forms and configure them in Studio for clinical coders to code form data within Vault Coder.

Accessing Studio

To access the Studio study design and configuration area, click the Studio tab in the primary navigation bar.

Access Studio from the Studio tab

Once you click the Studio tab, Vault opens the My Studies page, a listing of Studies in your vault. By default, this page shows automated deployment studies. You can select the Manual radio button to show your manual deployment Studies (those studies created prior to the 19R3 release that have not been upgraded to automatic deployments), or navigate to those manual studies directly from the breadcrumb menu.

Use the Automatic and Manual buttons to switch the deployment types
Use the Automatic and Manual buttons to switch the deployment types

From the My Studies page, you can click a Study Master to open the Study Instances page. Then, you can click a Study Instance to open Studio for that instance. For manual deployment Studies, clicking the Study opens the Studio area for that study right away.

Configuring a Form for Coding

To enable a Form for coding, you must assign a Form Type, a Dictionary Release, a Synonym List, a Stop List, and a Verbatim Item. You can then also assign Related Items and make selections for Coding Method.

Once Code Requests exist for a Form, Vault locks the coding configuration for that assigned Dictionary Release. You can no longer edit that selection. If you need to update the configuration, you can contact Veeva Services. They can work with you to update the configuration and existing Code Requests. See details below.
  1. Navigate to the Form Definition that you want to configure for coding in Studio’s Design view.
  2. Click the Form to display the form’s Properties panel.
  3. In the Coding Configuration section, click Edit. Vault opens the Coding Configuration dialog.
  4. Select a Form Type. See details about these options below.
  5. If you selected Other for Form Type, name that type in Form Type Other.
  6. Select a Dictionary Release. Only Dictionary Releases related to the Form Type display. If you need to use a Dictionary Release that is not in this drop-down, contact your Veeva Services representative.
  7. Select a Synonym List to assign a Synonym List to this Form. A coding administrator can update this assignment later from Coder Tools > Study Settings > Form Configuration.
  8. Select a Verbatim Item.
  9. Optional: Select a Stop List to assign a Stop List to this Form. A coding administrator can update this assignment later from Coder Tools > Study Settings > Form Configuration.
  10. The remaining configuration in this dialog is optional. See details about Related Items and Coding Methods below.
  11. Click Save.
Coding Configuration dialog for a ConMed Form
Coding Configuration dialog for a ConMed (WHODrug) Form
Coding Configuration dialog for an AE (MedDRA) Form
Coding Configuration dialog for an AE (MedDRA) Form

Editing Configuration with Existing Code Requests

When you make changes to your form configuration while your study is in execution (and there are existing Code Requests), Vault applies your configuration changes right away.

Vault does not allow you to update the Dictionary Release when there are existing requests without performing additional steps. If you need to switch to an earlier version, or switch dictionary type (MedDRA to WHODrug or vice versa), you can work with Veeva Services to make a mid-stream change.

If you need to update to a newer version of the dictionary, your organization’s coding administrator should upversion from Coder Tools.

Contact your Veeva Services representative about your needs. They can remove existing Code Requests and remove your configuration. Then, you can reconfigure your Form using the new dictionary selection. Lastly, a lead data manager can run the Reconstitute Code Requests job to recreate all of the removed Code Requests using the updated configuration.

Form Types

Which dictionary type applies to your Form depends on the Form Type you selected.

If you selected ConMed, WHODrug B3 and C3 dictionary versions are available for selection in Dictionary Release. If you selected AE, MedDRA dictionary versions are available for selection in Dictionary Release.

If you selected Other, you can choose from any available dictionary version. Which dictionary type you choose (WHODrug or MedDRA) informs which options are available to you for Related Items and Coding Methods.

You can configure data collection Items on your Form to display their values in the Code Request Properties panel. Coders can then look at those values as a reference when making coding decisions.

You can define which Items display and their order from the Related Items section of the Coding Configuration dialog. Any Items that you add here display in the Code Request Properties panel. If you remove a Related Item, it no longer displays in that panel.

Based on your selection for Form Type, Vault automatically adds a set of Related Item rows. You can then select Items to pair to the Type in each row.

Don’t use an Item that includes unknown dates as a Start Date or Stop Date related item.

To add a Related Item:

  1. In the Coding Configuration dialog, click Add Related Item.
  2. Select an Item. The options here are all data collection Items on the Form you’re editing.
  3. Select a Type. Note that the available Types are limited by the Form Type.
  4. If you selected Other for Type, enter a name for the type in the If Type Other field.
  5. Click Save.

The order of the Related Items in the Coding Configuration dialog determines the order in which those Items display in the Code Request Properties panel. You can change this order at any time.

To reorder Related Items:

  1. Locate the Related Item you want to move in the Coding Configuration dialog.
  2. Click and drag a Related Item into a different position in the list.
  3. Repeat steps 1 and 2 until finished.
  4. Click Save.

You can delete Related Items to remove them from the coding configuration.

This action does not remove the Item from the Form or delete the Item Definition record.

To delete a Related Item:

  1. Locate the Related Item you want to delete in the Coding Configuration dialog.
  2. Click Delete (X). Vault deletes the Related Item configuration.
  3. Click Save.

Coding Methods

You can apply configuration settings based on the methods an organization uses for coding. For coding to WHODrug, some organizations may use Indication and/or Route to help code. For coding to MedDra, an organization may use Serious Adverse Events (SAE) to help prioritize which verbatims should get coded first.

The Coding Methods that you can select or deselect in Studio are dependent on the Form Type selected.

Coding Methods for ConMed (WHODrug) Forms

If your ConMed form has data collection Items for Indication, Route, or both Indication and Route, you can configure the Form to use those values coding decisions.

Indication

Enabled
(Checkbox selected)
When the Indication checkbox is selected:
  • Coder displays an Indication column in the Code Request Listing table to inform manual coding decisions.
  • Vault stores the Indication value in each Synonym and references it when autocoding from that Synonym List.
  • Indication informs how Vault groups Code Requests in Grouped mode.
Disabled
(Checkbox not selected)
When the Indication checkbox is not selected:
  • Coder does not display an Indication column in the Code Request Listing table.
  • Vault does not store Indication in Synonym records.
  • Indication does not inform how Vault groups Code Requests in Grouped mode.

Route

Enabled
(Checkbox selected)
When the Route checkbox is selected:
  • Coder displays a Route column in the Code Request Listing table to inform manual coding decisions.
  • Vault stores the Route value in each Synonym and references it when autocoding from that Synonym List.
  • Route informs how Vault groups Code Requests in Grouped mode.
Disabled
(Checkbox not selected)
When the Route checkbox is not selected:
  • Coder does not display a Route column in the Code Request Listing table.
  • Vault does not store Route in Synonym records.
  • Route does not inform how Vault groups Code Requests in Grouped mode.

Coding Methods for AE (MedDRA) Forms

If your AE form has a data collection Item for Seriousness, you can configure the Form to use that value for coding decisions. When you include Seriousness as a coding method, coders can more easily identify serious adverse events and prioritize them for coding.

Enabled
(Checkbox selected)
When the Enable SAE Prioritization checkbox is selected:
  • Coder displays a Seriousness column in the Code Request Listing table to inform manual coding decisions.
  • Vault stores the Seriousness value in each Synonym and references it when autocoding from that Synonym List.
  • Seriousness informs how Vault groups Code Requests in Grouped mode.
Disabled
(Checkbox not selected)
When the Enable SAE Prioritization checkbox is not selected:
  • Coder does not display a Seriousness column in the Code Request Listing table.
  • Vault does not store Seriousness in Synonym records.
  • Seriousness does not inform how Vault groups Code Requests in Grouped mode.

How to Remove the Coding Configuration

To remove the coding configuration from a Form:

  1. Navigate to the Form Definition that you want to remove the configuration from in Studio’s Design view.
  2. Click the Form to display the form’s Properties panel.
  3. In the Coding Configuration section, click Edit. Vault opens the Coding Configuration dialog.
  4. Click Delete.

Which permissions control your access depends on when your vault was created. If your vault uses the Role by Study feature, see the first section, Role by Study Permissions. If your vault does not use the CDMS Role by Study feature, see the second section, Profile Permissions.

Role by Study Permissions

Users with the standard CDMS Study Designer study role can perform the actions described above by default. If your vault uses custom Study Roles, your study role must provide the following permissions:

Type Permission Label Controls
Functional Permission Studio Tab

Ability to access the Studio tab

Learn more about Study Roles.

Profile Permissions

Users with the standard Vault Owner security profile can perform the actions described above by default.


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