Coder Study Settings

There are various settings that control available functionality, such as Synonym List review and autocoding scope, within Vault Coder that you can manage from Coder Tools. Vault Coder includes application-level settings, which Vault uses as a “template” and applies to new Studies. You can customize these from Coder Tools > Default Study Settings.

You can then customize settings on a study-by-study basis from Coder Tools > Study Settings.

Prerequisites

Users with the CDMS Clinical Coders Administrator study role can perform the actions described above by default. If your vault uses custom Study Roles, you must have a Study Role that grants the following permissions:

Type Permission Label Controls
Standard Tab Coder Tools Tab

Ability to access the Coder Tools tab

Functional Permission Manage Coder Study Settings

Ability to edit Study Settings in Coder Tools

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

Learn more about Study Roles.


Accessing Coder Tools

To access the Coder Tools administration area, click the Tools tab in the primary navigation bar, and then click Coder Tools.

Access Coder Tools from the Tools Tab

Once in Coder Tools, you can click the sub-tabs to navigate to different areas within.

Default Study Settings

You can modify the default settings at the application level from Coder Tools > Default Study Settings (formerly known as Application Settings) These settings are the default settings for each new Study in your vault. You can configure settings for an individual Study from Coder Tools > Study Settings.

Default Study Settings

How to Edit Default Study Settings

Changes application-level settings apply to all future Studies in your vault.

To change application-level settings:

  1. Navigate to Coder Tools > Default Study Settings.
  2. Click Edit. Edit button

  3. Choose Yes or No for each setting that you would like to change. See descriptions of each setting below. Default Study Settings in Edit mode

  4. Click Save.

Study Settings

You can modify settings on a study-by-study basis from Coder Tools > Study Settings. Changes here only apply to the selected Study. By default, the study-level settings selections match the application-level settings.

Study Settings

From Coder Tools > Study Settings, you can also:

How to Edit Study Settings

If you change a setting in Coder Tools > Study Settings, Vault applies the updated settings immediatelys. Take care when updating settings after coding is in progress for a Study.

To edit study-level settings:

  1. Navigate to Coder Tools > Study Settings.
  2. Use the Study Selector to select your Study:
    • Type your study’s Name in the Search Studies field.
    • Click your Study to select it. Study Selector
  3. Click Edit. Edit button

  4. Select Yes or No for each setting that you would like to change. See descriptions of each setting below. Study Settings in Edit mode

  5. Click Save.

Available Settings

The following nine (9) settings are available:

The Autocoded Code Requests Require Review setting was removed in the 21R1 (April 2021) release as part of the Coder Approval Workflow feature.

Coding System

The Coding System setting controls whether you are using Vault Coder or a third party system for your clinical coding activities. By default, this setting is set to Vault Coder. To use a third party system, select Third Party System for this setting. Work with your Veeva Services representative and your organization’s development team to create an integration between Vault CDMS and your coding system of choice to code your EDC data.

Add to Synonym Lists by Default

The Add to Synonym Lists by Default setting controls whether Vault automatically generates a Synonym List for a Study.

Selection Default Impact
Yes Vault automatically generates a Synonym List at Study creation and adds Synonyms to it by default as coders code. Coders can choose to not add to the Synonym List while coding.
No   Vault does not generate a Synonym List. You must manually create a Synonym List and coders will have to choose to add to the Synonym List.

Review Additions to Synonym Lists

The Review Additions to Synonym Lists setting controls whether or not Vault automatically adds Synonyms to the Synonym List after a coder assigns a code while Add to Synonym List is toggled to Y (Yes).

Selection Default Impact
Yes   You can review and approve (or reject or delete) Synonyms before they are used to inform autocoding and suggestions. Before you review them, Synonyms remain in the Pending Review status. If there is already a Synonym record with the exact same name, including Indication and Route (for WHODrug), and that Synonym is Active or Pending Review, Vault Coder doesn’t add a new Synonym for you to review. If there is not an exact match, or the exact match is Rejected, then Vault creates a new Synonym (in the Pending Review status) for you to review.
No Vault automatically approves and adds Synonyms to the Synonym List and uses them to inform autocoding and suggestions right away. Vault first checks if there is an exact match for the verbatim in an existing Synonym, including Indication and Route for WHODrug. If there is an exact match, Vault does not create an additional Synonym record. If there is not an exact match, Vault creates a new Synonym record in the Active status.

Autocode from Dictionary

The Autocode from Dictionary setting controls whether or not Vault autocodes from the coding dictionary, in addition to the Synonym List.

Selection Default Impact
Yes   Vault autocodes from both the Synonym List and the dictionary. Vault first attempts to autocode from the Synonym List. If there are no matches, Vault then attempts to find a match in the coding dictionary.
No Vault autocodes based only on the Synonym List (not from the dictionary).

Code With ATCs

The Code With ATCs setting controls whether Vault stores ATCs for WHODrug Code Requests during coding. Some users prefer to code without ATCs because they haven’t coded with ATCs or feel that it doesn’t provide any additional value to their analysis.

Once there is at least one Code Request with an assigned code, Vault locks this setting for the Study.

Selection Default Impact
Yes Vault stores ATCs for WHODrug Code Requests during coding.
No   Vault does not store ATCs for WHODrug Code Requests during coding.

Store Preferred Base

The Store Preferred Base setting controls whether or not Vault stores the Preferred Base column for WHODrug B3 and C3 terms.

Selection Default Impact
Yes
(For Studies created after 21R1)
Vault stores the Preferred Base for WHODrug Code Requests, displaying this column in the Dictionary panel and including the Preferred Base in extracts.
No
(For Studies created before 21R1)
Vault does not store the Preferred Base.

Enable Approval Workflow

The Enable Approval Workflow feature controls whether or not a Study uses the Coder Approval Workflow feature.

Selection Default Impact
Yes The Study uses the Coder Approval Workflow feature. Once a coder assigns a code to a Code Request, it moves into the Pending Approval status and a coder manager must approve the code before the request moves into the Coded status.
No The Study does not use the Coder Approval Workflow feature. When a coder assigns a code to a Code Request, that request moves directly into the Coded status.

Enable Rejection Reason

The Enable Rejection Reason feature controls whether or not Vault posts the rejection reason as a Note on the Code Request as part of the Coder Approval Workflow. This option is only available if Enable Approval Workflow is set to Yes.

Selection Default Impact
Yes When a coder manager rejects the assigned code, Vault posts a Note on the Code Request with the provided Rejection Reason while moving the request into the Rejected status.
No When a coder manager rejects the assigned code, the Code Request moves to the Rejected status, but Vault doesn’t post a note.

Grouping Criteria for Verbatims Includes Query Status

The Grouping Criteria for Verbatims Includes Query Status feature controls whether or not Vault includes Query Status in the grouping criteria when grouping Code Requests for group querying.

Selection Default Impact
Yes
(For Studies created after 21R1)
Vault includes Query Status in the grouping criteria for grouping Code Requests.
No
(For Studies created before 21R1)
Vault doesn’t include Query Status in the grouping criteria, and instead groups Code Requests by Verbatim, Coding Status, and Assigned Code, as well as Indication, Route, and Seriousness where applicable.