Managing Study Settings

After creating your Study, you can update various study-level settings related to data collection in your study from Studio > Settings. Note that your selections within Studio > Settings, including the Signature Definition, are not versioned.

Accessing Studio

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

Once you click the Studio tab, you have the option to open either Studies, a listing of Studies in your vault, or Library. 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.

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.

Settings includes five (5) configuration sections: Study Properties, Integrations, General, Subject ID Generation, and Signature Definitions.

How to Edit Settings

To edit your study’s general and subject ID generation settings:

1. Navigate to your Study in Studio and open the Settings tab.

2. Click Edit.

3. Make your changes.
4. Click Save.

Study Properties

You can define informational properties for your study from the Study Properties section of Studio > Settings. There is no functionality associated with these properties. Vault displays the values for these properties in study listings across Vault CDMS.

Setting	Description
Study Phase	Select your study’s Study Phase.
Study Status	Select your study’s current Study Status.

Integration

You can edit the External ID for your study from the Integrations section of Studio > Settings.

Setting	Description
External ID	Enter the External ID for your Study.

General

You can define general settings related to data collection in your study from the General section of Studio > Settings.

Setting	Controls
Standard Date Format	Select a date format to use across the study.
Twelve Hour Time	Select Yes to use twelve hour time, and select No to use twenty-four hour time.
Enable Other Specify - Reason for Change	Select Yes to enable this feature. When enabled, users can enter a custom Reason for Change.
Enable Other Specify - Intentionally Left Blank	Select Yes to enable this feature. When enabled, users can enter a custom reason for Intentionally Left Blank.
Open Query on Out of Range Event Dates	This setting controls whether or not Vault creates out of window queries by default. When set to Yes, Vault creates queries when an Event Date is outside of the configured window or is in the future (based on event-level configuration) if the Open Query property is set to Inherit or Yes. When disabled (No selected), Vault does not create system-generated queries against Event Dates when set to Inherit or No. This setting only determines the default for out of window query creation (any Events with Inherit for Open Query). You can override this for individual events by choosing Yes or No for Open Query. Learn more.
Enable Team Query Restrictions	This setting controls whether not Vault enforces query team restrictions. When enforced, Vault prevents users from closing any queries created by a user on a different Team. Teams are assigned by Study Role. When this feature isn’t enabled, users with permission to close queries may close any query they have permission to access.
Enable Veeva Randomization	Select Yes to enable the Veeva Randomziation module. Otherwise, leave this set to No.
Enable Local Labs	Select Yes to enable the Local Labs module. Otherwise, leave this set to No.
Enable Protocol Deviations	This setting controls the availability of the Protocol Deviations feature. Enabling this feature allows monitoring users to create and respond to Protocol Deviations. When enabled, Vault adds the Protocol Deviations configuration area to Studio and the Create Protocol Deviation rule action. Learn more.
Enable Additive Review	Select Yes to enable the Additive Review feature for your Study. When enabled, users can perform SDV and DMR on an ad hoc basis for Event Dates and Items with the requirement mode set to No Review.
Enable Subject Status Date Rollback	Select Yes to clear the status date when a subject’s status is rolled back after a data change causes a Set Subject Status rule to evaluate as false, that previously evaluated as true. Select No to keep the status date when a subject’s status is rolled back.

Subject ID Generation

Vault automatically creates subject IDs for each Subject. At Casebook creation, Vault adds the subject ID SCR-####, incrementing by one for each Subject at the Site. Once the subject passes screening, Vault updates the subject ID to a new auto-generated ID based on the Subject ID Generation configuration.

Setting	Description
Subject Id Gen Format	Enter the format for Subject IDs in the Study. In the current release, Vault supports including or excluding leading zeroes, padded spaces, and #### to show data type. See details below.
Subject Id Gen Type	Select the type of auto-generated Subject ID to use. See details below.
Subject Id Range Start	Enter a number at which to start numbering Subject IDs. For example, if you enter “001” here, Vault numbers the first Subject ID in the Study with “001”.
Subject Id Range End	Enter a number at which to end numbering Subject IDs. For example, if you enter “9999” here, Vault starts numbering over after subject -9999.

Subject ID Format Tokens

The following tokens are available for use in the Subject ID Gen Format setting:

• study.name: Name field value for the Study
• study.oid: External ID (formerly known as “OID”) field value for the Study
• country.name: Name field value for the Study Country of the subject’s Site
• site.number: Site Number (name__v) field value for the subject’s Site

Use # for system-generated numbers. Surround each section of the subject ID format with curly braces {}.

In a Study with the Subject Id Gen Format set to {site.number-####}-{####}, where a Site Number is “101” and the Subject ID Range Start is “0001”, generates the Subject ID “101-0001”, incrementing the second number by 1 for each new Subject at the Site (101-0002, 101-0003, and so on.)

Subject ID Generation Types

Vault supports the following standard Subject ID generation methods. Contact Veeva Services to discuss other generation methods, such as setting the Subject ID based on your organization’s randomization system.

Type	Description
by_site	Vault generates unique (at the Site level) Subject IDs based on the template in the Subject ID Gen Format field within the range of the Subject Id Range Start and Subject Id Range End.
manual	A data entry user enters the subject ID in a configured data collection Item (a Status-type Item within a Screening- or Enrolled-type Event).
external	Use this method if your organization plans to import Subjects from another system. Contact your Veeva Services representative for details about connecting external systems to Vault CDMS for subject import.

Related Permissions

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

Type	Permission Label	Controls
Functional Permission	Studio Tab	Ability to access the Studio tab
Security Profile	Objects: Organization: Create, Edit	Ability to create and edit Organization object records
Security Profile	Objects: Study: Create, Edit	Ability to create and edit Study object records
Security Profile	Objects: Study Configuration: Edit	Ability to edit study settings that exist in the study’s Study Configuration record
Security Profile	Objects: Signature Definition: Create, Edit	Ability to create and edit Signature Definition object records