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.

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.

Settings includes three (3) configuration sections: General, Subject ID Generation, and Signature Definitions.

Studio > Settings

How to Edit General & Subject ID Generation 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. Edit button for Settings

  3. Make your changes.
  4. Click Save.

General Settings

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.

Subject ID Generation Settings

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.

Once subjects exist in your Study, you will no longer be able to update these settings.
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.protocol: Protocol field value for the Study
  • study.oid: External ID 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.

Signature Definitions

In order for your investigators in your Study to provide eSignatures, you must configure a Signature Definition object record related to your Study.

The buttons and actions related to signatures will not display for investigator users until you create a Signature Definition.

In the current release, Vault CDMS only supports a single Signature Definition per Study. Vault disables the + New Signature Definition button once you create a Signature Definition.

Users with the appropriate permissions can also configure Signature Definitions from Admin > Business Admin. See Configuring Signature Definitions in Business Admin for details.

Create a Signature Definition

To create your study’s Signature Definition:

  1. Navigate to your Study in Studio.
  2. Scroll to Settings > Signature Definitions.
  3. Click + New Signature Definition.

    New Signature Definition button

  4. In the Signature Definition dialog:
    • Select a signature Methodology from the drop-down list.
    • Enter a Meaning for signatures in your study.
    • Enter a Legal Reason for signatures in your study.
    • Optional: Enter an External ID for your Signature Definition. Signature Definition dialog
  5. Click Save.
  6. Vault saves your changes and applies them to any future signatures in your Study.

Edit a Signature Definition

You can edit your Signature Definition as needed from Studio > Settings. Editing the Signature Definition when there are already signed forms in your study invalidates all existing signatures. Any signed forms revert to the Completed status. Investigators will have to re-sign all previously signed forms.

To edit your Signature Definition:

  1. Locate your Signature Definition in Settings > Signature Definitions.
  2. From the Actions menu, select Edit.
  3. Make any required changes in the Signature Definition dialog.
  4. Click Save.
  5. Vault saves your changes and applies them to any future signatures in your Study.

Next Steps

Once you finish configuring your Study, you can move on to creating your study’s design in the rest of Studio.

See Designing a Study in Studio for more details.

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 Vault Owner security profile or the Design security profile and 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

Profile Permissions

Users with the Vault Owner security profile can perform the actions described above by default. If your vault uses custom security profiles, you must have the following permissions:

Type Permission Label Controls
Security Profile Tabs: Studio 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